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Infant’s COVID-19–related myocardial injury reversed

Article Type
Changed
Thu, 08/26/2021 - 15:55

Reports of signs of heart failure in adults with COVID-19 have been rare – just four such cases have been published since the outbreak started in China – and now a team of pediatric cardiologists in New York have reported a case of acute but reversible myocardial injury in an infant with COVID-19.

Madhu S. et al. J Am Coll Cardiol Case Rep. 2020 doi: 10.1016/j.jaccas.2020.09.031
Chest radiograph showing cardiomegaly, bibasilar opacities,
and right upper lobe atelectasis.


The 2-month-old infant went home after more than 2 weeks in the hospital with no apparent lingering cardiac effects of the illness and not needing any oral heart failure medications, Madhu Sharma, MD, of the Children’s Hospital and Montefiore in New York and colleagues reported in JACC Case Reports. With close follow-up, the child’s left ventricle size and systolic function have remained normal and mitral regurgitation resolved. The case report didn’t mention the infant’s gender.

But before the straightforward postdischarge course emerged, the infant was in a precarious state, and Dr. Sharma and her team were challenged to diagnose the underlying causes.

The child, who was born about 7 weeks premature, first came to the hospital having turned blue after choking on food. Nonrebreather mask ventilation was initiated in the ED, and an examination detected a holosystolic murmur. A test for COVID-19 was negative, but a later test was positive, and a chest x-ray exhibited cardiomegaly and signs of fluid and inflammation in the lungs.

An electrocardiogram detected sinus tachycardia, ST-segment depression and other anomalies in cardiac function. Further investigation with a transthoracic ECG showed severely depressed left ventricle systolic function with an ejection fraction of 30%, severe mitral regurgitation, and normal right ventricular systolic function.

Treatment included remdesivir and intravenous antibiotics. Through the hospital course, the patient was extubated to noninvasive ventilation, reintubated, put on intravenous steroid (methylprednisolone) and low-molecular-weight heparin, extubated, and tested throughout for cardiac function.

By day 14, left ventricle size and function normalized, and while the mitral regurgitation remained severe, it improved later without HF therapies. Left ventricle ejection fraction had recovered to 60%, and key cardiac biomarkers had normalized. On day 16, milrinone was discontinued, and the care team determined the patient no longer needed oral heart failure therapies.

“Most children with COVID-19 are either asymptomatic or have mild symptoms, but our case shows the potential for reversible myocardial injury in infants with COVID-19,” said Dr. Sharma. “Testing for COVID-19 in children presenting with signs and symptoms of heart failure is very important as we learn more about the impact of this virus.”

Dr. Sharma and coauthors have no relevant financial relationships to disclose.

SOURCE: Sharma M et al. JACC Case Rep. 2020. doi: 10.1016/j.jaccas.2020.09.031.

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Reports of signs of heart failure in adults with COVID-19 have been rare – just four such cases have been published since the outbreak started in China – and now a team of pediatric cardiologists in New York have reported a case of acute but reversible myocardial injury in an infant with COVID-19.

Madhu S. et al. J Am Coll Cardiol Case Rep. 2020 doi: 10.1016/j.jaccas.2020.09.031
Chest radiograph showing cardiomegaly, bibasilar opacities,
and right upper lobe atelectasis.


The 2-month-old infant went home after more than 2 weeks in the hospital with no apparent lingering cardiac effects of the illness and not needing any oral heart failure medications, Madhu Sharma, MD, of the Children’s Hospital and Montefiore in New York and colleagues reported in JACC Case Reports. With close follow-up, the child’s left ventricle size and systolic function have remained normal and mitral regurgitation resolved. The case report didn’t mention the infant’s gender.

But before the straightforward postdischarge course emerged, the infant was in a precarious state, and Dr. Sharma and her team were challenged to diagnose the underlying causes.

The child, who was born about 7 weeks premature, first came to the hospital having turned blue after choking on food. Nonrebreather mask ventilation was initiated in the ED, and an examination detected a holosystolic murmur. A test for COVID-19 was negative, but a later test was positive, and a chest x-ray exhibited cardiomegaly and signs of fluid and inflammation in the lungs.

An electrocardiogram detected sinus tachycardia, ST-segment depression and other anomalies in cardiac function. Further investigation with a transthoracic ECG showed severely depressed left ventricle systolic function with an ejection fraction of 30%, severe mitral regurgitation, and normal right ventricular systolic function.

Treatment included remdesivir and intravenous antibiotics. Through the hospital course, the patient was extubated to noninvasive ventilation, reintubated, put on intravenous steroid (methylprednisolone) and low-molecular-weight heparin, extubated, and tested throughout for cardiac function.

By day 14, left ventricle size and function normalized, and while the mitral regurgitation remained severe, it improved later without HF therapies. Left ventricle ejection fraction had recovered to 60%, and key cardiac biomarkers had normalized. On day 16, milrinone was discontinued, and the care team determined the patient no longer needed oral heart failure therapies.

“Most children with COVID-19 are either asymptomatic or have mild symptoms, but our case shows the potential for reversible myocardial injury in infants with COVID-19,” said Dr. Sharma. “Testing for COVID-19 in children presenting with signs and symptoms of heart failure is very important as we learn more about the impact of this virus.”

Dr. Sharma and coauthors have no relevant financial relationships to disclose.

SOURCE: Sharma M et al. JACC Case Rep. 2020. doi: 10.1016/j.jaccas.2020.09.031.

Reports of signs of heart failure in adults with COVID-19 have been rare – just four such cases have been published since the outbreak started in China – and now a team of pediatric cardiologists in New York have reported a case of acute but reversible myocardial injury in an infant with COVID-19.

Madhu S. et al. J Am Coll Cardiol Case Rep. 2020 doi: 10.1016/j.jaccas.2020.09.031
Chest radiograph showing cardiomegaly, bibasilar opacities,
and right upper lobe atelectasis.


The 2-month-old infant went home after more than 2 weeks in the hospital with no apparent lingering cardiac effects of the illness and not needing any oral heart failure medications, Madhu Sharma, MD, of the Children’s Hospital and Montefiore in New York and colleagues reported in JACC Case Reports. With close follow-up, the child’s left ventricle size and systolic function have remained normal and mitral regurgitation resolved. The case report didn’t mention the infant’s gender.

But before the straightforward postdischarge course emerged, the infant was in a precarious state, and Dr. Sharma and her team were challenged to diagnose the underlying causes.

The child, who was born about 7 weeks premature, first came to the hospital having turned blue after choking on food. Nonrebreather mask ventilation was initiated in the ED, and an examination detected a holosystolic murmur. A test for COVID-19 was negative, but a later test was positive, and a chest x-ray exhibited cardiomegaly and signs of fluid and inflammation in the lungs.

An electrocardiogram detected sinus tachycardia, ST-segment depression and other anomalies in cardiac function. Further investigation with a transthoracic ECG showed severely depressed left ventricle systolic function with an ejection fraction of 30%, severe mitral regurgitation, and normal right ventricular systolic function.

Treatment included remdesivir and intravenous antibiotics. Through the hospital course, the patient was extubated to noninvasive ventilation, reintubated, put on intravenous steroid (methylprednisolone) and low-molecular-weight heparin, extubated, and tested throughout for cardiac function.

By day 14, left ventricle size and function normalized, and while the mitral regurgitation remained severe, it improved later without HF therapies. Left ventricle ejection fraction had recovered to 60%, and key cardiac biomarkers had normalized. On day 16, milrinone was discontinued, and the care team determined the patient no longer needed oral heart failure therapies.

“Most children with COVID-19 are either asymptomatic or have mild symptoms, but our case shows the potential for reversible myocardial injury in infants with COVID-19,” said Dr. Sharma. “Testing for COVID-19 in children presenting with signs and symptoms of heart failure is very important as we learn more about the impact of this virus.”

Dr. Sharma and coauthors have no relevant financial relationships to disclose.

SOURCE: Sharma M et al. JACC Case Rep. 2020. doi: 10.1016/j.jaccas.2020.09.031.

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FROM JACC CASE REPORTS

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Key clinical point: Children presenting with COVID-19 should be tested for heart failure.

Major finding: A 2-month-old infant with COVID-19 had acute but reversible myocardial injury.

Study details: Single case report.

Disclosures: Dr. Sharma, MD, has no relevant financial relationships to disclose.

Source: Sharma M et al. JACC Case Rep. 2020. doi: 10.1016/j.jaccas.2020.09.031.

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Vaginal cleansing protocol curbs deep SSIs after cesarean

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Changed
Fri, 12/04/2020 - 14:43

A quality improvement plan incorporating vaginal cleansing and azithromycin significantly reduced surgical-site infections (SSIs) after cesarean deliveries, reported Johanna Quist-Nelson, MD, of the University of North Carolina, Chapel Hill.

Dr. Johanna Quist-Nelson

“Surgical site infections after a cesarean delivery are more common if the patient is in labor or has ruptured membranes,” she said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.. 

Two options to decrease the risk of SSIs after cesarean for those patients in labor or with ruptured membranes are vaginal cleansing and azithromycin, given in addition to preoperative antibiotics, Dr. Quist-Nelson said. She and her colleagues conducted a quality improvement study of the effects of a stepwise implementation of vaginal cleansing and azithromycin to reduce SSIs at cesarean delivery in this high-risk population. The data were collected from 2016 to 2019 at Thomas Jefferson University, Philadelphia.

“We aimed to decrease our SSI rate by 30% by adopting an intervention of cleansing followed by azithromycin,” she said.

The researchers added vaginal cleansing to the SSI prevention protocol in January 2017, with the addition of azithromycin in March 2018. Vaginal cleansing involved 30 seconds of anterior to posterior cleaning prior to urinary catheter placement. Azithromycin was given at a dose of 500 mg intravenously in addition to preoperative antibiotics and within an hour of cesarean delivery.

A total of 1,033 deliveries qualified for the study by being in labor or with ruptured membranes; of these 291 were performed prior to the interventions, 335 received vaginal cleansing only, and 407 received vaginal cleansing and azithromycin. The average age of the participants was 30 years; approximately 42% were Black, and 32% were White.
 

Cleansing protocol reduces SSIs

Overall, the rate of SSIs was 22% in the standard care group, 17% in the vaginal cleansing group, and 15% in the vaginal cleansing plus azithromycin group. When broken down by infection type, no deep SSI occurred in the vaginal cleansing or cleansing plus azithromycin group, compared with 2% of the standard care group (P = .009). In addition, endometritis, which is an organ-space SSI, was significantly lower in the cleansing group (10%) and the cleansing plus azithromycin group (11%), compared with the standard care group (16%).

The study findings were limited by factors including the use of EMRs for collection of data, and given that it is a quality improvement study, there is a potential lack of generalizability to other institutions. The study focused on patients at high risk for SSI and the use of the Plan-Do-Study-Act (PDSA) method of conducting the research, Dr. Quist-Nelson said. Compared with standard care, the implementation of vaginal cleansing reduced the SSI rate by 33%, with no significantly further change in SSI after the addition of azithromycin, she concluded.
 

Data sharing boosts compliance

In a question-and-answer session, Dr. Quist-Nelson noted that povidone iodine (Betadine) was chosen for vaginal cleansing because it was easily accessible at her institution, but that patients with allergies were given chlorhexidine. The cleansing itself was “primarily vaginal, not a full vulvar cleansing,” she clarified. The cleansing was performed immediately before catheter placement and included the urethra.

When asked about strategies to increase compliance, Dr. Quist-Nelson noted that sharing data was valuable, namely “reporting to our group the current compliance,” as well as sharing information by email and discussing it during multidisciplinary rounds.

The study was a quality improvement project and not a randomized trial, so the researchers were not able to tease out the impact of vaginal cleansing from the impact of azithromycin, Dr. Quist-Nelson said.

Based on her results, Dr. Quist-Nelson said she would recommend the protocol for use in patients who require cesarean delivery after being in labor or having ruptured membranes, and that “there are trials to support the use of both interventions.”

The results suggest opportunities for further randomized trials, including examination of the use of oral versus IV azithromycin, she added.

The study received no outside funding. Dr. Quist-Nelson had no financial conflicts to disclose.

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A quality improvement plan incorporating vaginal cleansing and azithromycin significantly reduced surgical-site infections (SSIs) after cesarean deliveries, reported Johanna Quist-Nelson, MD, of the University of North Carolina, Chapel Hill.

Dr. Johanna Quist-Nelson

“Surgical site infections after a cesarean delivery are more common if the patient is in labor or has ruptured membranes,” she said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.. 

Two options to decrease the risk of SSIs after cesarean for those patients in labor or with ruptured membranes are vaginal cleansing and azithromycin, given in addition to preoperative antibiotics, Dr. Quist-Nelson said. She and her colleagues conducted a quality improvement study of the effects of a stepwise implementation of vaginal cleansing and azithromycin to reduce SSIs at cesarean delivery in this high-risk population. The data were collected from 2016 to 2019 at Thomas Jefferson University, Philadelphia.

“We aimed to decrease our SSI rate by 30% by adopting an intervention of cleansing followed by azithromycin,” she said.

The researchers added vaginal cleansing to the SSI prevention protocol in January 2017, with the addition of azithromycin in March 2018. Vaginal cleansing involved 30 seconds of anterior to posterior cleaning prior to urinary catheter placement. Azithromycin was given at a dose of 500 mg intravenously in addition to preoperative antibiotics and within an hour of cesarean delivery.

A total of 1,033 deliveries qualified for the study by being in labor or with ruptured membranes; of these 291 were performed prior to the interventions, 335 received vaginal cleansing only, and 407 received vaginal cleansing and azithromycin. The average age of the participants was 30 years; approximately 42% were Black, and 32% were White.
 

Cleansing protocol reduces SSIs

Overall, the rate of SSIs was 22% in the standard care group, 17% in the vaginal cleansing group, and 15% in the vaginal cleansing plus azithromycin group. When broken down by infection type, no deep SSI occurred in the vaginal cleansing or cleansing plus azithromycin group, compared with 2% of the standard care group (P = .009). In addition, endometritis, which is an organ-space SSI, was significantly lower in the cleansing group (10%) and the cleansing plus azithromycin group (11%), compared with the standard care group (16%).

The study findings were limited by factors including the use of EMRs for collection of data, and given that it is a quality improvement study, there is a potential lack of generalizability to other institutions. The study focused on patients at high risk for SSI and the use of the Plan-Do-Study-Act (PDSA) method of conducting the research, Dr. Quist-Nelson said. Compared with standard care, the implementation of vaginal cleansing reduced the SSI rate by 33%, with no significantly further change in SSI after the addition of azithromycin, she concluded.
 

Data sharing boosts compliance

In a question-and-answer session, Dr. Quist-Nelson noted that povidone iodine (Betadine) was chosen for vaginal cleansing because it was easily accessible at her institution, but that patients with allergies were given chlorhexidine. The cleansing itself was “primarily vaginal, not a full vulvar cleansing,” she clarified. The cleansing was performed immediately before catheter placement and included the urethra.

When asked about strategies to increase compliance, Dr. Quist-Nelson noted that sharing data was valuable, namely “reporting to our group the current compliance,” as well as sharing information by email and discussing it during multidisciplinary rounds.

The study was a quality improvement project and not a randomized trial, so the researchers were not able to tease out the impact of vaginal cleansing from the impact of azithromycin, Dr. Quist-Nelson said.

Based on her results, Dr. Quist-Nelson said she would recommend the protocol for use in patients who require cesarean delivery after being in labor or having ruptured membranes, and that “there are trials to support the use of both interventions.”

The results suggest opportunities for further randomized trials, including examination of the use of oral versus IV azithromycin, she added.

The study received no outside funding. Dr. Quist-Nelson had no financial conflicts to disclose.

A quality improvement plan incorporating vaginal cleansing and azithromycin significantly reduced surgical-site infections (SSIs) after cesarean deliveries, reported Johanna Quist-Nelson, MD, of the University of North Carolina, Chapel Hill.

Dr. Johanna Quist-Nelson

“Surgical site infections after a cesarean delivery are more common if the patient is in labor or has ruptured membranes,” she said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.. 

Two options to decrease the risk of SSIs after cesarean for those patients in labor or with ruptured membranes are vaginal cleansing and azithromycin, given in addition to preoperative antibiotics, Dr. Quist-Nelson said. She and her colleagues conducted a quality improvement study of the effects of a stepwise implementation of vaginal cleansing and azithromycin to reduce SSIs at cesarean delivery in this high-risk population. The data were collected from 2016 to 2019 at Thomas Jefferson University, Philadelphia.

“We aimed to decrease our SSI rate by 30% by adopting an intervention of cleansing followed by azithromycin,” she said.

The researchers added vaginal cleansing to the SSI prevention protocol in January 2017, with the addition of azithromycin in March 2018. Vaginal cleansing involved 30 seconds of anterior to posterior cleaning prior to urinary catheter placement. Azithromycin was given at a dose of 500 mg intravenously in addition to preoperative antibiotics and within an hour of cesarean delivery.

A total of 1,033 deliveries qualified for the study by being in labor or with ruptured membranes; of these 291 were performed prior to the interventions, 335 received vaginal cleansing only, and 407 received vaginal cleansing and azithromycin. The average age of the participants was 30 years; approximately 42% were Black, and 32% were White.
 

Cleansing protocol reduces SSIs

Overall, the rate of SSIs was 22% in the standard care group, 17% in the vaginal cleansing group, and 15% in the vaginal cleansing plus azithromycin group. When broken down by infection type, no deep SSI occurred in the vaginal cleansing or cleansing plus azithromycin group, compared with 2% of the standard care group (P = .009). In addition, endometritis, which is an organ-space SSI, was significantly lower in the cleansing group (10%) and the cleansing plus azithromycin group (11%), compared with the standard care group (16%).

The study findings were limited by factors including the use of EMRs for collection of data, and given that it is a quality improvement study, there is a potential lack of generalizability to other institutions. The study focused on patients at high risk for SSI and the use of the Plan-Do-Study-Act (PDSA) method of conducting the research, Dr. Quist-Nelson said. Compared with standard care, the implementation of vaginal cleansing reduced the SSI rate by 33%, with no significantly further change in SSI after the addition of azithromycin, she concluded.
 

Data sharing boosts compliance

In a question-and-answer session, Dr. Quist-Nelson noted that povidone iodine (Betadine) was chosen for vaginal cleansing because it was easily accessible at her institution, but that patients with allergies were given chlorhexidine. The cleansing itself was “primarily vaginal, not a full vulvar cleansing,” she clarified. The cleansing was performed immediately before catheter placement and included the urethra.

When asked about strategies to increase compliance, Dr. Quist-Nelson noted that sharing data was valuable, namely “reporting to our group the current compliance,” as well as sharing information by email and discussing it during multidisciplinary rounds.

The study was a quality improvement project and not a randomized trial, so the researchers were not able to tease out the impact of vaginal cleansing from the impact of azithromycin, Dr. Quist-Nelson said.

Based on her results, Dr. Quist-Nelson said she would recommend the protocol for use in patients who require cesarean delivery after being in labor or having ruptured membranes, and that “there are trials to support the use of both interventions.”

The results suggest opportunities for further randomized trials, including examination of the use of oral versus IV azithromycin, she added.

The study received no outside funding. Dr. Quist-Nelson had no financial conflicts to disclose.

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Obesity, hypoxia predict severity in children with COVID-19

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Obesity and hypoxia at the time of hospital admission predicted more severe disease in children diagnosed with COVID-19, based on data from 281 patients at 8 locations.

Manifestations of COVID-19 in children include respiratory disease similar to that seen in adults, but the full spectrum of disease in children has been studied mainly in single settings or with a focus on one clinical manifestation, wrote Danielle M. Fernandes, MD, of Albert Einstein College of Medicine, New York, and colleagues.

In a study published in the Journal of Pediatrics, the researchers identified 281 children hospitalized with COVID-19 and/or multisystem inflammatory syndrome in children (MIS-C) at 8 sites in Connecticut, New Jersey, and New York. A total of 143 (51%) had respiratory disease, 69 (25%) had MIS-C, and 69 (25%) had other manifestations of illness including 32 patients with gastrointestinal problems, 21 infants with fever, 6 cases of neurologic disease, 6 cases of diabetic ketoacidosis, and 4 patients with other indications. The median age of the patients was 10 years, 60% were male, 51% were Hispanic, and 23% were non-Hispanic Black. The most common comorbidities were obesity (34%) and asthma (14%).
 

Independent predictors of disease severity in children found

After controlling for multiple variables, obesity and hypoxia at hospital admission were significant independent predictors of severe respiratory disease, with odds ratios of 3.39 and 4.01, respectively. In addition, lower absolute lymphocyte count (OR, 8.33 per unit decrease in 109 cells/L) and higher C-reactive protein (OR, 1.06 per unit increase in mg/dL) were significantly predictive of severe MIS-C (P = .001 and P = .017, respectively).

“The association between weight and severe respiratory COVID-19 is consistent with the adult literature; however, the mechanisms of this association require further study,” Dr. Fernandes and associates noted.

Overall, children with MIS-C were significantly more likely to be non-Hispanic Black, compared with children with respiratory disease, an 18% difference. However, neither race/ethnicity nor socioeconomic status were significant predictors of disease severity, the researchers wrote.

During the study period, 7 patients (2%) died and 114 (41%) were admitted to the ICU.

“We found a wide array of clinical manifestations in children and youth hospitalized with SARS-CoV-2,” Dr. Fernandes and associates wrote. Notably, gastrointestinal symptoms, ocular symptoms, and dermatologic symptoms have rarely been noted in adults with COVID-19, but occurred in more than 30% of the pediatric patients.

“We also found that SARS-CoV-2 can be an incidental finding in a substantial number of hospitalized pediatric patients,” the researchers said.

The findings were limited by several factors including a population of patients only from Connecticut, New Jersey, and New York, and the possibility that decisions on hospital and ICU admission may have varied by location, the researchers said. In addition, approaches may have varied in the absence of data on the optimal treatment of MIS-C.

“This study builds on the growing body of evidence showing that mortality in hospitalized pediatric patients is low, compared with adults,” Dr. Fernandes and associates said. “However, it highlights that the young population is not universally spared from morbidity, and that even previously healthy children and youth can develop severe disease requiring supportive therapy.”
 

Findings confirm other clinical experience

The study was important to show that, “although most children are spared severe illness from COVID-19, some children are hospitalized both with acute COVID-19 respiratory disease, with MIS-C and with a range of other complications,” Adrienne Randolph, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, said in an interview.

Dr. Randolph said she was not surprised by the study findings, “as we are also seeing these types of complications at Boston Children’s Hospital where I work.”

Additional research is needed on the outcomes of these patients, “especially the longer-term sequelae of having COVID-19 or MIS-C early in life,” she emphasized.

The take-home message to clinicians from the findings at this time is to be aware that children and adolescents can become severely ill from COVID-19–related complications, said Dr. Randolph. “Some of the laboratory values on presentation appear to be associated with disease severity.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Randolph disclosed funding from the Centers for Disease Control and Prevention to lead the Overcoming COVID-19 Study in U.S. Children and Adults.

SOURCE: Fernandes DM et al. J Pediatr. 2020 Nov 13. doi: 10.1016/j.jpeds.2020.11.016.

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Obesity and hypoxia at the time of hospital admission predicted more severe disease in children diagnosed with COVID-19, based on data from 281 patients at 8 locations.

Manifestations of COVID-19 in children include respiratory disease similar to that seen in adults, but the full spectrum of disease in children has been studied mainly in single settings or with a focus on one clinical manifestation, wrote Danielle M. Fernandes, MD, of Albert Einstein College of Medicine, New York, and colleagues.

In a study published in the Journal of Pediatrics, the researchers identified 281 children hospitalized with COVID-19 and/or multisystem inflammatory syndrome in children (MIS-C) at 8 sites in Connecticut, New Jersey, and New York. A total of 143 (51%) had respiratory disease, 69 (25%) had MIS-C, and 69 (25%) had other manifestations of illness including 32 patients with gastrointestinal problems, 21 infants with fever, 6 cases of neurologic disease, 6 cases of diabetic ketoacidosis, and 4 patients with other indications. The median age of the patients was 10 years, 60% were male, 51% were Hispanic, and 23% were non-Hispanic Black. The most common comorbidities were obesity (34%) and asthma (14%).
 

Independent predictors of disease severity in children found

After controlling for multiple variables, obesity and hypoxia at hospital admission were significant independent predictors of severe respiratory disease, with odds ratios of 3.39 and 4.01, respectively. In addition, lower absolute lymphocyte count (OR, 8.33 per unit decrease in 109 cells/L) and higher C-reactive protein (OR, 1.06 per unit increase in mg/dL) were significantly predictive of severe MIS-C (P = .001 and P = .017, respectively).

“The association between weight and severe respiratory COVID-19 is consistent with the adult literature; however, the mechanisms of this association require further study,” Dr. Fernandes and associates noted.

Overall, children with MIS-C were significantly more likely to be non-Hispanic Black, compared with children with respiratory disease, an 18% difference. However, neither race/ethnicity nor socioeconomic status were significant predictors of disease severity, the researchers wrote.

During the study period, 7 patients (2%) died and 114 (41%) were admitted to the ICU.

“We found a wide array of clinical manifestations in children and youth hospitalized with SARS-CoV-2,” Dr. Fernandes and associates wrote. Notably, gastrointestinal symptoms, ocular symptoms, and dermatologic symptoms have rarely been noted in adults with COVID-19, but occurred in more than 30% of the pediatric patients.

“We also found that SARS-CoV-2 can be an incidental finding in a substantial number of hospitalized pediatric patients,” the researchers said.

The findings were limited by several factors including a population of patients only from Connecticut, New Jersey, and New York, and the possibility that decisions on hospital and ICU admission may have varied by location, the researchers said. In addition, approaches may have varied in the absence of data on the optimal treatment of MIS-C.

“This study builds on the growing body of evidence showing that mortality in hospitalized pediatric patients is low, compared with adults,” Dr. Fernandes and associates said. “However, it highlights that the young population is not universally spared from morbidity, and that even previously healthy children and youth can develop severe disease requiring supportive therapy.”
 

Findings confirm other clinical experience

The study was important to show that, “although most children are spared severe illness from COVID-19, some children are hospitalized both with acute COVID-19 respiratory disease, with MIS-C and with a range of other complications,” Adrienne Randolph, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, said in an interview.

Dr. Randolph said she was not surprised by the study findings, “as we are also seeing these types of complications at Boston Children’s Hospital where I work.”

Additional research is needed on the outcomes of these patients, “especially the longer-term sequelae of having COVID-19 or MIS-C early in life,” she emphasized.

The take-home message to clinicians from the findings at this time is to be aware that children and adolescents can become severely ill from COVID-19–related complications, said Dr. Randolph. “Some of the laboratory values on presentation appear to be associated with disease severity.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Randolph disclosed funding from the Centers for Disease Control and Prevention to lead the Overcoming COVID-19 Study in U.S. Children and Adults.

SOURCE: Fernandes DM et al. J Pediatr. 2020 Nov 13. doi: 10.1016/j.jpeds.2020.11.016.

 

Obesity and hypoxia at the time of hospital admission predicted more severe disease in children diagnosed with COVID-19, based on data from 281 patients at 8 locations.

Manifestations of COVID-19 in children include respiratory disease similar to that seen in adults, but the full spectrum of disease in children has been studied mainly in single settings or with a focus on one clinical manifestation, wrote Danielle M. Fernandes, MD, of Albert Einstein College of Medicine, New York, and colleagues.

In a study published in the Journal of Pediatrics, the researchers identified 281 children hospitalized with COVID-19 and/or multisystem inflammatory syndrome in children (MIS-C) at 8 sites in Connecticut, New Jersey, and New York. A total of 143 (51%) had respiratory disease, 69 (25%) had MIS-C, and 69 (25%) had other manifestations of illness including 32 patients with gastrointestinal problems, 21 infants with fever, 6 cases of neurologic disease, 6 cases of diabetic ketoacidosis, and 4 patients with other indications. The median age of the patients was 10 years, 60% were male, 51% were Hispanic, and 23% were non-Hispanic Black. The most common comorbidities were obesity (34%) and asthma (14%).
 

Independent predictors of disease severity in children found

After controlling for multiple variables, obesity and hypoxia at hospital admission were significant independent predictors of severe respiratory disease, with odds ratios of 3.39 and 4.01, respectively. In addition, lower absolute lymphocyte count (OR, 8.33 per unit decrease in 109 cells/L) and higher C-reactive protein (OR, 1.06 per unit increase in mg/dL) were significantly predictive of severe MIS-C (P = .001 and P = .017, respectively).

“The association between weight and severe respiratory COVID-19 is consistent with the adult literature; however, the mechanisms of this association require further study,” Dr. Fernandes and associates noted.

Overall, children with MIS-C were significantly more likely to be non-Hispanic Black, compared with children with respiratory disease, an 18% difference. However, neither race/ethnicity nor socioeconomic status were significant predictors of disease severity, the researchers wrote.

During the study period, 7 patients (2%) died and 114 (41%) were admitted to the ICU.

“We found a wide array of clinical manifestations in children and youth hospitalized with SARS-CoV-2,” Dr. Fernandes and associates wrote. Notably, gastrointestinal symptoms, ocular symptoms, and dermatologic symptoms have rarely been noted in adults with COVID-19, but occurred in more than 30% of the pediatric patients.

“We also found that SARS-CoV-2 can be an incidental finding in a substantial number of hospitalized pediatric patients,” the researchers said.

The findings were limited by several factors including a population of patients only from Connecticut, New Jersey, and New York, and the possibility that decisions on hospital and ICU admission may have varied by location, the researchers said. In addition, approaches may have varied in the absence of data on the optimal treatment of MIS-C.

“This study builds on the growing body of evidence showing that mortality in hospitalized pediatric patients is low, compared with adults,” Dr. Fernandes and associates said. “However, it highlights that the young population is not universally spared from morbidity, and that even previously healthy children and youth can develop severe disease requiring supportive therapy.”
 

Findings confirm other clinical experience

The study was important to show that, “although most children are spared severe illness from COVID-19, some children are hospitalized both with acute COVID-19 respiratory disease, with MIS-C and with a range of other complications,” Adrienne Randolph, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, said in an interview.

Dr. Randolph said she was not surprised by the study findings, “as we are also seeing these types of complications at Boston Children’s Hospital where I work.”

Additional research is needed on the outcomes of these patients, “especially the longer-term sequelae of having COVID-19 or MIS-C early in life,” she emphasized.

The take-home message to clinicians from the findings at this time is to be aware that children and adolescents can become severely ill from COVID-19–related complications, said Dr. Randolph. “Some of the laboratory values on presentation appear to be associated with disease severity.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Randolph disclosed funding from the Centers for Disease Control and Prevention to lead the Overcoming COVID-19 Study in U.S. Children and Adults.

SOURCE: Fernandes DM et al. J Pediatr. 2020 Nov 13. doi: 10.1016/j.jpeds.2020.11.016.

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COVID-19 impacts women’s contraception choices

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Fri, 12/04/2020 - 11:21

The rate of unintended pregnancies in the United States has decreased to approximately 45%, based on data published in 2016, and “for the first time in many years, this decrease affected women of all race/ethnicity, income levels, and education levels,” Eve Espey, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.

Changes in contraceptive choices drove much of this decrease, said Dr. Espey, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.

Dr. Eve Espey


“What is really striking is the very large increase in use of the IUD,” she noted. However, the increased use of IUDs has raised concerns about coercive tactics being used to push for IUD use in communities of color.

“The focus we should have is on reproductive autonomy and not on unintended pregnancy, a metric that is classist and racist and may value the reproduction of some groups over others,” Dr. Espey said. Previous studies have suggested that providers are biased in how they promote long-acting reversible contraception (LARC), and reports from patients suggest that women and people of color particularly may feel marginalized, not heard, and coerced, she noted.
 

Help patients feel empowered

Overall, the goal of contraception should be to empower women and people to make the reproductive decisions that are best for them. “My own approach to contraceptive counseling has changed over the years; I currently start by asking if the patient wants to talk about contraception,” Dr. Espey said.

The COVID-19 pandemic has impacted many women’s reproductive options and plans, she said.

A survey showed that after COVID-19, more than 40% of women reported changing their plans about childbearing, 34% wanted to get pregnant later, and 33% reported trouble getting birth control or getting an appointment with a health care provider, she said.

ACOG issued a statement in March 2020 about the provision of contraception and how contraception is an essential component of comprehensive health care. The COVID-19 ACOG guidance on contraception includes use of telehealth for services including screening new patients, offering prescriptions and refills as appropriate, and managing side effects. Providers can counsel patients on the use of emergency contraception and provide advance prescriptions for ulipristal acetate, and ideally provide a year’s worth of prescription refills to reduce pharmacy visits, although not all insurance companies allow this, Dr. Espey noted.

ACOG’s COVID-19 guidance on the use of LARCs includes preserving access when possible, and focusing on postpartum contraception as a key access point.

“The postpartum period is a very convenient time for patients who want contraceptives, including LARC,” especially since they are already in the hospital setting, Dr. Espey said. However, it is important to preserve patients’ reproductive autonomy and avoid placing barriers to LARC removal for those who request it, she emphasized.
 

Consider MEC categories for contraception

When advising patients about contraception, Dr. Espey noted the development of a simple app with the U.S. Medical Eligibility Criteria (MEC) as a useful tool. The app includes the four MEC categories based on the latest evidence-based guidance from the Centers for Disease Control and Prevention on contraceptive practice.

Patients in category 1 have no restriction on the use of a particular contraceptive method; category 2 means that “advantages generally outweigh the theoretical or proven risks”; in category 3, these risks usually outweigh the advantages; and category 4 indicates “unacceptable health risk if the contraceptive method is used,” according to the MEC.

“What complicates category 3 is that many patients have a condition that is associated with adverse outcomes in pregnancy,” Dr. Espey noted, “So it is even more important that category 3 options only be considered if other options are not available or not acceptable to the patient,”

For example, a patient with complicated diabetes who wants depot medroxyprogesterone acetate (DMPA) for contraception for a year must weigh the benefits with the theoretical risk of thromboembolic disease related to a higher dose progestin, and the fact that the injection is not reversible in the case of an adverse event. “Close follow-up is recommended for patients using contraception with category 3 recommendations,” Dr. Espey emphasized.

Some new elements of contraception that are ongoing in the pandemic health care setting include increased pharmacist prescribing of hormonal contraception, Dr. Espey said. Over-the-counter access to contraception is not yet an option, but a progestin-only pill will likely be the first, she added.

Although the Essure birth control implant is no longer available in the United States, new options for a contraceptive patch (Twirla [ethinyl estradiol and levonorgestrel] and Xulane [ethinyl estradiol and norelgestromin]) offer weekly contraceptive options for women with a body mass index less than 30 kg/m2.
 

Annovera offers more options

The newest choice on the market is Annovera, a flexible ring that delivers 150 mcg/day of segesterone acetate and 13 mcg/day of ethinyl estradiol. The ring is meant to remain in place for 21 days, with 7 days out, to repeat for a year.

During the question-and-answer session, Dr. Espey was asked whether it would be an off-label use to leave Annovera in continuously. Although this has not been studied, there is no biologically plausible reason not to leave it in for a year without taking it out. In either case, this is a patient-controlled LARC, she said.

Overall, “it remains to be seen how Annovera will do, as a potentially exciting, new, long-acting option” she said. “A major advantage is that it is controlled by the user,” she noted. However, “the price point will be very important as well.”

As for the off-label use by women with a BMI greater than 29 kg/m2, it is complicated. Two women with higher BMIs enrolled in clinical trials developed venous thromboembolisms, so an increased risk can’t be ruled out, although the good news is that BMI has not been shown to impact effectiveness of the product, she added.
 

IUDs appropriate for younger women

When asked for her guidelines about IUD options in the absence of head-to-head trials, Dr. Espey said that she often recommends either Mirena and Liletta. These levonorgestrel-releasing IUDS are essentially the same, can be used off label for 7 years (both are currently Food and Drug Administration approved for 6 years), and have a favorable bleeding profile. Other IUDs are marketed as having a smaller diameter designed for increased patient comfort with insertion, but she views this as less important than bleeding profile and duration given the length of time the device is in place.

Dr. Espey added that she doesn’t see age as a barrier to IUD use, and that the evidence does not support an increased risk of infertility. In fact, “we are seeing a higher demand among younger and nulliparous women.”

“We should respect the reproductive autonomy and the choices that our patients make,” Dr. Espey concluded.

Dr. Espey had no relevant financial disclosures. She is a member of the Ob.Gyn. News editorial advisory board.

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The rate of unintended pregnancies in the United States has decreased to approximately 45%, based on data published in 2016, and “for the first time in many years, this decrease affected women of all race/ethnicity, income levels, and education levels,” Eve Espey, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.

Changes in contraceptive choices drove much of this decrease, said Dr. Espey, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.

Dr. Eve Espey


“What is really striking is the very large increase in use of the IUD,” she noted. However, the increased use of IUDs has raised concerns about coercive tactics being used to push for IUD use in communities of color.

“The focus we should have is on reproductive autonomy and not on unintended pregnancy, a metric that is classist and racist and may value the reproduction of some groups over others,” Dr. Espey said. Previous studies have suggested that providers are biased in how they promote long-acting reversible contraception (LARC), and reports from patients suggest that women and people of color particularly may feel marginalized, not heard, and coerced, she noted.
 

Help patients feel empowered

Overall, the goal of contraception should be to empower women and people to make the reproductive decisions that are best for them. “My own approach to contraceptive counseling has changed over the years; I currently start by asking if the patient wants to talk about contraception,” Dr. Espey said.

The COVID-19 pandemic has impacted many women’s reproductive options and plans, she said.

A survey showed that after COVID-19, more than 40% of women reported changing their plans about childbearing, 34% wanted to get pregnant later, and 33% reported trouble getting birth control or getting an appointment with a health care provider, she said.

ACOG issued a statement in March 2020 about the provision of contraception and how contraception is an essential component of comprehensive health care. The COVID-19 ACOG guidance on contraception includes use of telehealth for services including screening new patients, offering prescriptions and refills as appropriate, and managing side effects. Providers can counsel patients on the use of emergency contraception and provide advance prescriptions for ulipristal acetate, and ideally provide a year’s worth of prescription refills to reduce pharmacy visits, although not all insurance companies allow this, Dr. Espey noted.

ACOG’s COVID-19 guidance on the use of LARCs includes preserving access when possible, and focusing on postpartum contraception as a key access point.

“The postpartum period is a very convenient time for patients who want contraceptives, including LARC,” especially since they are already in the hospital setting, Dr. Espey said. However, it is important to preserve patients’ reproductive autonomy and avoid placing barriers to LARC removal for those who request it, she emphasized.
 

Consider MEC categories for contraception

When advising patients about contraception, Dr. Espey noted the development of a simple app with the U.S. Medical Eligibility Criteria (MEC) as a useful tool. The app includes the four MEC categories based on the latest evidence-based guidance from the Centers for Disease Control and Prevention on contraceptive practice.

Patients in category 1 have no restriction on the use of a particular contraceptive method; category 2 means that “advantages generally outweigh the theoretical or proven risks”; in category 3, these risks usually outweigh the advantages; and category 4 indicates “unacceptable health risk if the contraceptive method is used,” according to the MEC.

“What complicates category 3 is that many patients have a condition that is associated with adverse outcomes in pregnancy,” Dr. Espey noted, “So it is even more important that category 3 options only be considered if other options are not available or not acceptable to the patient,”

For example, a patient with complicated diabetes who wants depot medroxyprogesterone acetate (DMPA) for contraception for a year must weigh the benefits with the theoretical risk of thromboembolic disease related to a higher dose progestin, and the fact that the injection is not reversible in the case of an adverse event. “Close follow-up is recommended for patients using contraception with category 3 recommendations,” Dr. Espey emphasized.

Some new elements of contraception that are ongoing in the pandemic health care setting include increased pharmacist prescribing of hormonal contraception, Dr. Espey said. Over-the-counter access to contraception is not yet an option, but a progestin-only pill will likely be the first, she added.

Although the Essure birth control implant is no longer available in the United States, new options for a contraceptive patch (Twirla [ethinyl estradiol and levonorgestrel] and Xulane [ethinyl estradiol and norelgestromin]) offer weekly contraceptive options for women with a body mass index less than 30 kg/m2.
 

Annovera offers more options

The newest choice on the market is Annovera, a flexible ring that delivers 150 mcg/day of segesterone acetate and 13 mcg/day of ethinyl estradiol. The ring is meant to remain in place for 21 days, with 7 days out, to repeat for a year.

During the question-and-answer session, Dr. Espey was asked whether it would be an off-label use to leave Annovera in continuously. Although this has not been studied, there is no biologically plausible reason not to leave it in for a year without taking it out. In either case, this is a patient-controlled LARC, she said.

Overall, “it remains to be seen how Annovera will do, as a potentially exciting, new, long-acting option” she said. “A major advantage is that it is controlled by the user,” she noted. However, “the price point will be very important as well.”

As for the off-label use by women with a BMI greater than 29 kg/m2, it is complicated. Two women with higher BMIs enrolled in clinical trials developed venous thromboembolisms, so an increased risk can’t be ruled out, although the good news is that BMI has not been shown to impact effectiveness of the product, she added.
 

IUDs appropriate for younger women

When asked for her guidelines about IUD options in the absence of head-to-head trials, Dr. Espey said that she often recommends either Mirena and Liletta. These levonorgestrel-releasing IUDS are essentially the same, can be used off label for 7 years (both are currently Food and Drug Administration approved for 6 years), and have a favorable bleeding profile. Other IUDs are marketed as having a smaller diameter designed for increased patient comfort with insertion, but she views this as less important than bleeding profile and duration given the length of time the device is in place.

Dr. Espey added that she doesn’t see age as a barrier to IUD use, and that the evidence does not support an increased risk of infertility. In fact, “we are seeing a higher demand among younger and nulliparous women.”

“We should respect the reproductive autonomy and the choices that our patients make,” Dr. Espey concluded.

Dr. Espey had no relevant financial disclosures. She is a member of the Ob.Gyn. News editorial advisory board.

The rate of unintended pregnancies in the United States has decreased to approximately 45%, based on data published in 2016, and “for the first time in many years, this decrease affected women of all race/ethnicity, income levels, and education levels,” Eve Espey, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.

Changes in contraceptive choices drove much of this decrease, said Dr. Espey, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.

Dr. Eve Espey


“What is really striking is the very large increase in use of the IUD,” she noted. However, the increased use of IUDs has raised concerns about coercive tactics being used to push for IUD use in communities of color.

“The focus we should have is on reproductive autonomy and not on unintended pregnancy, a metric that is classist and racist and may value the reproduction of some groups over others,” Dr. Espey said. Previous studies have suggested that providers are biased in how they promote long-acting reversible contraception (LARC), and reports from patients suggest that women and people of color particularly may feel marginalized, not heard, and coerced, she noted.
 

Help patients feel empowered

Overall, the goal of contraception should be to empower women and people to make the reproductive decisions that are best for them. “My own approach to contraceptive counseling has changed over the years; I currently start by asking if the patient wants to talk about contraception,” Dr. Espey said.

The COVID-19 pandemic has impacted many women’s reproductive options and plans, she said.

A survey showed that after COVID-19, more than 40% of women reported changing their plans about childbearing, 34% wanted to get pregnant later, and 33% reported trouble getting birth control or getting an appointment with a health care provider, she said.

ACOG issued a statement in March 2020 about the provision of contraception and how contraception is an essential component of comprehensive health care. The COVID-19 ACOG guidance on contraception includes use of telehealth for services including screening new patients, offering prescriptions and refills as appropriate, and managing side effects. Providers can counsel patients on the use of emergency contraception and provide advance prescriptions for ulipristal acetate, and ideally provide a year’s worth of prescription refills to reduce pharmacy visits, although not all insurance companies allow this, Dr. Espey noted.

ACOG’s COVID-19 guidance on the use of LARCs includes preserving access when possible, and focusing on postpartum contraception as a key access point.

“The postpartum period is a very convenient time for patients who want contraceptives, including LARC,” especially since they are already in the hospital setting, Dr. Espey said. However, it is important to preserve patients’ reproductive autonomy and avoid placing barriers to LARC removal for those who request it, she emphasized.
 

Consider MEC categories for contraception

When advising patients about contraception, Dr. Espey noted the development of a simple app with the U.S. Medical Eligibility Criteria (MEC) as a useful tool. The app includes the four MEC categories based on the latest evidence-based guidance from the Centers for Disease Control and Prevention on contraceptive practice.

Patients in category 1 have no restriction on the use of a particular contraceptive method; category 2 means that “advantages generally outweigh the theoretical or proven risks”; in category 3, these risks usually outweigh the advantages; and category 4 indicates “unacceptable health risk if the contraceptive method is used,” according to the MEC.

“What complicates category 3 is that many patients have a condition that is associated with adverse outcomes in pregnancy,” Dr. Espey noted, “So it is even more important that category 3 options only be considered if other options are not available or not acceptable to the patient,”

For example, a patient with complicated diabetes who wants depot medroxyprogesterone acetate (DMPA) for contraception for a year must weigh the benefits with the theoretical risk of thromboembolic disease related to a higher dose progestin, and the fact that the injection is not reversible in the case of an adverse event. “Close follow-up is recommended for patients using contraception with category 3 recommendations,” Dr. Espey emphasized.

Some new elements of contraception that are ongoing in the pandemic health care setting include increased pharmacist prescribing of hormonal contraception, Dr. Espey said. Over-the-counter access to contraception is not yet an option, but a progestin-only pill will likely be the first, she added.

Although the Essure birth control implant is no longer available in the United States, new options for a contraceptive patch (Twirla [ethinyl estradiol and levonorgestrel] and Xulane [ethinyl estradiol and norelgestromin]) offer weekly contraceptive options for women with a body mass index less than 30 kg/m2.
 

Annovera offers more options

The newest choice on the market is Annovera, a flexible ring that delivers 150 mcg/day of segesterone acetate and 13 mcg/day of ethinyl estradiol. The ring is meant to remain in place for 21 days, with 7 days out, to repeat for a year.

During the question-and-answer session, Dr. Espey was asked whether it would be an off-label use to leave Annovera in continuously. Although this has not been studied, there is no biologically plausible reason not to leave it in for a year without taking it out. In either case, this is a patient-controlled LARC, she said.

Overall, “it remains to be seen how Annovera will do, as a potentially exciting, new, long-acting option” she said. “A major advantage is that it is controlled by the user,” she noted. However, “the price point will be very important as well.”

As for the off-label use by women with a BMI greater than 29 kg/m2, it is complicated. Two women with higher BMIs enrolled in clinical trials developed venous thromboembolisms, so an increased risk can’t be ruled out, although the good news is that BMI has not been shown to impact effectiveness of the product, she added.
 

IUDs appropriate for younger women

When asked for her guidelines about IUD options in the absence of head-to-head trials, Dr. Espey said that she often recommends either Mirena and Liletta. These levonorgestrel-releasing IUDS are essentially the same, can be used off label for 7 years (both are currently Food and Drug Administration approved for 6 years), and have a favorable bleeding profile. Other IUDs are marketed as having a smaller diameter designed for increased patient comfort with insertion, but she views this as less important than bleeding profile and duration given the length of time the device is in place.

Dr. Espey added that she doesn’t see age as a barrier to IUD use, and that the evidence does not support an increased risk of infertility. In fact, “we are seeing a higher demand among younger and nulliparous women.”

“We should respect the reproductive autonomy and the choices that our patients make,” Dr. Espey concluded.

Dr. Espey had no relevant financial disclosures. She is a member of the Ob.Gyn. News editorial advisory board.

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Menstrual cup use increases risk of IUD expulsion

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Fri, 12/04/2020 - 09:32

Menstrual cup use is becoming increasingly popular as an option for menstrual hygiene among women in the United States, but little is known about the potential for IUD expulsion with menstrual cup use, Jill Long, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Dr. Jill E. Long

Dr. Long cited a 2019 Internet survey of IUD users in which 11% reported menstrual cup use; reports of IUD expulsion were approximately three times higher among menstrual cup users. The results of the survey were limited by the self-reported responses and lack of data on when the expulsions occurred related to menstrual cup use.

Similar concerns about expulsion surfaced in an ongoing phase 3, randomized trial designed to support the marketing application of the Mona Lisa NT Cu380 Mini IUD, which is not currently approved in the United States.

“Nine months into the study, more expulsions were observed than expected, particularly among menstrual cup users,” said Dr. Long, medical officer and project officer for the Contraceptive Clinical Trials Network at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers then began to advise study participants to avoid menstrual cup use, and to collect data on use of menstrual hygiene products.

The preliminary study results reported by Dr. Long included 1,092 women assigned in a 4:1 ratio to receive the Mona Lisa NT Cu380 Mini and ParaGard, an IUD approved in the United States. Participants had follow-up visits at 6 weeks and at 3, 6, 12, 24, and 36 months after placement to verify the IUD position.

At 34 months, the overall rate of IUD expulsion was 9%. Of 277 women who reported menstrual cup use, the expulsion rate was 18%, compared with a 6% expulsion rates among the 704 women who reported tampon use.
 

Patient behavior persists despite advisory

Overall IUD expulsion was not significantly different among patients enrolled before and after the advisory against menstrual cup use (9.8% vs. 8.8%, respectively). In addition, menstrual cup use did not decrease after the implementation of the advisory (24% preadvisory vs. 28% post advisory).

The expulsion rates between menstrual cup users and nonusers were significantly different at both 12 months (14% vs. 5%) and 24 months (21% vs. 6%).

In addition, the researchers created a category of accidental self-removal, defined as the percent of expulsions occurring at the time the menstrual hygiene product was removed. Accidental self-removal was significantly higher among menstrual cup users, compared with tampon users (43% vs. 10%).

Study limitations included study blinding with regard to IUD type, parity, and age, so the impact of these factors on expulsion remains unclear, Dr. Long said. In addition, data on menstrual hygiene product use was collected retrospectively for the first 9 months, and no data were available on the impact on expulsion of combined use of menstrual cups and tampons.

Despite the apparent lack of impact of counseling, “women should be informed of the increased risk of expulsion if they choose to use menstrual cups concurrently with copper IUDs,” Dr. Long concluded.
 

 

 

More data to come from further analysis

During a question-and-answer session following the presentation, Dr. Long was asked whether suction might contribute to expulsion. “We advised subjects to break the seal on the menstrual cup prior to removal, but we did not see a decrease in expulsion rates with menstrual cup use after this advisory,” she said.

“The type of menstrual cup may be a factor,” she added. “We still need to analyze the data by the type of menstrual cup used as different cups have different degrees of suction.”

When asked about the potential role of coital activity on expulsion, Dr. Long said that the researchers had not yet reviewed coital activity logs to compare expulsion data with the timing of sexual activity.

Any increased pregnancy rates among menstrual cup users are “unlikely, but we don’t know for sure,” she added.

The current study also did not evaluate quantitative differences in bleeding, and participants are using bleeding diaries, Dr. Long noted. She added that participants are able to report problems with bleeding to the study sites, and that these are captured as adverse events.

The study was supported by a partnership between NICHD and FHI 360, a nonprofit human development organization based in North Carolina, with FHI 360 funding from the Bill and Melinda Gates Foundation. Dr. Long had no financial conflicts to disclose.

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Menstrual cup use is becoming increasingly popular as an option for menstrual hygiene among women in the United States, but little is known about the potential for IUD expulsion with menstrual cup use, Jill Long, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Dr. Jill E. Long

Dr. Long cited a 2019 Internet survey of IUD users in which 11% reported menstrual cup use; reports of IUD expulsion were approximately three times higher among menstrual cup users. The results of the survey were limited by the self-reported responses and lack of data on when the expulsions occurred related to menstrual cup use.

Similar concerns about expulsion surfaced in an ongoing phase 3, randomized trial designed to support the marketing application of the Mona Lisa NT Cu380 Mini IUD, which is not currently approved in the United States.

“Nine months into the study, more expulsions were observed than expected, particularly among menstrual cup users,” said Dr. Long, medical officer and project officer for the Contraceptive Clinical Trials Network at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers then began to advise study participants to avoid menstrual cup use, and to collect data on use of menstrual hygiene products.

The preliminary study results reported by Dr. Long included 1,092 women assigned in a 4:1 ratio to receive the Mona Lisa NT Cu380 Mini and ParaGard, an IUD approved in the United States. Participants had follow-up visits at 6 weeks and at 3, 6, 12, 24, and 36 months after placement to verify the IUD position.

At 34 months, the overall rate of IUD expulsion was 9%. Of 277 women who reported menstrual cup use, the expulsion rate was 18%, compared with a 6% expulsion rates among the 704 women who reported tampon use.
 

Patient behavior persists despite advisory

Overall IUD expulsion was not significantly different among patients enrolled before and after the advisory against menstrual cup use (9.8% vs. 8.8%, respectively). In addition, menstrual cup use did not decrease after the implementation of the advisory (24% preadvisory vs. 28% post advisory).

The expulsion rates between menstrual cup users and nonusers were significantly different at both 12 months (14% vs. 5%) and 24 months (21% vs. 6%).

In addition, the researchers created a category of accidental self-removal, defined as the percent of expulsions occurring at the time the menstrual hygiene product was removed. Accidental self-removal was significantly higher among menstrual cup users, compared with tampon users (43% vs. 10%).

Study limitations included study blinding with regard to IUD type, parity, and age, so the impact of these factors on expulsion remains unclear, Dr. Long said. In addition, data on menstrual hygiene product use was collected retrospectively for the first 9 months, and no data were available on the impact on expulsion of combined use of menstrual cups and tampons.

Despite the apparent lack of impact of counseling, “women should be informed of the increased risk of expulsion if they choose to use menstrual cups concurrently with copper IUDs,” Dr. Long concluded.
 

 

 

More data to come from further analysis

During a question-and-answer session following the presentation, Dr. Long was asked whether suction might contribute to expulsion. “We advised subjects to break the seal on the menstrual cup prior to removal, but we did not see a decrease in expulsion rates with menstrual cup use after this advisory,” she said.

“The type of menstrual cup may be a factor,” she added. “We still need to analyze the data by the type of menstrual cup used as different cups have different degrees of suction.”

When asked about the potential role of coital activity on expulsion, Dr. Long said that the researchers had not yet reviewed coital activity logs to compare expulsion data with the timing of sexual activity.

Any increased pregnancy rates among menstrual cup users are “unlikely, but we don’t know for sure,” she added.

The current study also did not evaluate quantitative differences in bleeding, and participants are using bleeding diaries, Dr. Long noted. She added that participants are able to report problems with bleeding to the study sites, and that these are captured as adverse events.

The study was supported by a partnership between NICHD and FHI 360, a nonprofit human development organization based in North Carolina, with FHI 360 funding from the Bill and Melinda Gates Foundation. Dr. Long had no financial conflicts to disclose.

Menstrual cup use is becoming increasingly popular as an option for menstrual hygiene among women in the United States, but little is known about the potential for IUD expulsion with menstrual cup use, Jill Long, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Dr. Jill E. Long

Dr. Long cited a 2019 Internet survey of IUD users in which 11% reported menstrual cup use; reports of IUD expulsion were approximately three times higher among menstrual cup users. The results of the survey were limited by the self-reported responses and lack of data on when the expulsions occurred related to menstrual cup use.

Similar concerns about expulsion surfaced in an ongoing phase 3, randomized trial designed to support the marketing application of the Mona Lisa NT Cu380 Mini IUD, which is not currently approved in the United States.

“Nine months into the study, more expulsions were observed than expected, particularly among menstrual cup users,” said Dr. Long, medical officer and project officer for the Contraceptive Clinical Trials Network at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers then began to advise study participants to avoid menstrual cup use, and to collect data on use of menstrual hygiene products.

The preliminary study results reported by Dr. Long included 1,092 women assigned in a 4:1 ratio to receive the Mona Lisa NT Cu380 Mini and ParaGard, an IUD approved in the United States. Participants had follow-up visits at 6 weeks and at 3, 6, 12, 24, and 36 months after placement to verify the IUD position.

At 34 months, the overall rate of IUD expulsion was 9%. Of 277 women who reported menstrual cup use, the expulsion rate was 18%, compared with a 6% expulsion rates among the 704 women who reported tampon use.
 

Patient behavior persists despite advisory

Overall IUD expulsion was not significantly different among patients enrolled before and after the advisory against menstrual cup use (9.8% vs. 8.8%, respectively). In addition, menstrual cup use did not decrease after the implementation of the advisory (24% preadvisory vs. 28% post advisory).

The expulsion rates between menstrual cup users and nonusers were significantly different at both 12 months (14% vs. 5%) and 24 months (21% vs. 6%).

In addition, the researchers created a category of accidental self-removal, defined as the percent of expulsions occurring at the time the menstrual hygiene product was removed. Accidental self-removal was significantly higher among menstrual cup users, compared with tampon users (43% vs. 10%).

Study limitations included study blinding with regard to IUD type, parity, and age, so the impact of these factors on expulsion remains unclear, Dr. Long said. In addition, data on menstrual hygiene product use was collected retrospectively for the first 9 months, and no data were available on the impact on expulsion of combined use of menstrual cups and tampons.

Despite the apparent lack of impact of counseling, “women should be informed of the increased risk of expulsion if they choose to use menstrual cups concurrently with copper IUDs,” Dr. Long concluded.
 

 

 

More data to come from further analysis

During a question-and-answer session following the presentation, Dr. Long was asked whether suction might contribute to expulsion. “We advised subjects to break the seal on the menstrual cup prior to removal, but we did not see a decrease in expulsion rates with menstrual cup use after this advisory,” she said.

“The type of menstrual cup may be a factor,” she added. “We still need to analyze the data by the type of menstrual cup used as different cups have different degrees of suction.”

When asked about the potential role of coital activity on expulsion, Dr. Long said that the researchers had not yet reviewed coital activity logs to compare expulsion data with the timing of sexual activity.

Any increased pregnancy rates among menstrual cup users are “unlikely, but we don’t know for sure,” she added.

The current study also did not evaluate quantitative differences in bleeding, and participants are using bleeding diaries, Dr. Long noted. She added that participants are able to report problems with bleeding to the study sites, and that these are captured as adverse events.

The study was supported by a partnership between NICHD and FHI 360, a nonprofit human development organization based in North Carolina, with FHI 360 funding from the Bill and Melinda Gates Foundation. Dr. Long had no financial conflicts to disclose.

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Cervical cancer recurrence patterns differ after laparoscopic and open hysterectomy

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Changed
Thu, 12/03/2020 - 14:24

When cervical cancer recurs after radical hysterectomy, the likelihood of recurrence at certain sites and the timing of recurrence may be associated with the surgical approach, according to a retrospective study.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

Recurrence tended to occur sooner after minimally invasive surgery than after open abdominal surgery for cervical cancer, according to a propensity-matched analysis of data from 105 patients with recurrence.

And recurrence in the pelvic cavity and peritoneal carcinomatosis were more common after laparoscopic hysterectomy than after open surgery. Overall survival was similar between the groups, however.

The different patterns of recurrence may relate to dissemination of the disease during colpotomy, but the reasons are unknown, study author Giorgio Bogani, MD, PhD, said at the meeting sponsored by AAGL.

To examine patterns of recurrence after laparoscopic and open abdominal radical hysterectomy for cervical cancer, Dr. Bogani of the department of gynecologic surgery at the National Cancer Institute in Milan and colleagues analyzed data from patients with cervical cancer who developed recurrence after surgery at two oncologic referral centers between 1990 and 2018 (Int J Gynecol Cancer. 2020 Jul. doi: 10.1136/ijgc-2020-001381).

The investigators applied a propensity-matching algorithm to reduce possible confounding factors. They matched 35 patients who had recurrence after laparoscopic hysterectomy to 70 patients who had recurrence after open surgery. The groups had similar baseline characteristics.

As in the Laparoscopic Approach to Cervical Cancer (LACC) trial, patients who had minimally invasive surgery were more likely to have a worse disease-free survival, compared with patients who had open surgery, Dr. Bogani said. Patients who underwent laparoscopic radical hysterectomy had a median progression-free survival of 8 months, whereas patients who underwent open abdominal procedures had a median progression-free survival of 15.8 months.

Although vaginal, lymphatic, and distant recurrences were similar between the groups, a greater percentage of patients in the laparoscopic hysterectomy group had recurrence in the pelvic cavity (74% vs. 34%) and peritoneal carcinomatosis (17% vs. 1.5%).

The LACC trial, which found significantly lower disease-free and overall survival with laparoscopic hysterectomy, sent a “shockwave through the gynecologic oncology community” when it was published in 2018, said Masoud Azodi, MD, in a discussion following Dr. Bogani’s presentation.

Researchers have raised questions about that trial’s design and validity, noted Dr. Azodi, director of minimally invasive and robotic surgery at Yale University in New Haven, Conn.

It could be that local recurrences are attributable to surgical technique, rather than to the minimally invasive approach in itself, Dr. Azodi said. Prior studies of laparoscopic hysterectomy for cervical cancer had indicated better surgical outcomes and equivalent oncologic results, relative to open surgery.

Before the LACC trial, Dr. Bogani used the minimally invasive approach for almost all surgeries. Since then, he has performed open surgeries. If he were to use a minimally invasive approach now, it would be in the context of a clinical trial, Dr. Bogani said.

Dr. Bogani and Dr. Azodi had no relevant financial disclosures.

SOURCE: Bogani G et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.069.

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When cervical cancer recurs after radical hysterectomy, the likelihood of recurrence at certain sites and the timing of recurrence may be associated with the surgical approach, according to a retrospective study.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

Recurrence tended to occur sooner after minimally invasive surgery than after open abdominal surgery for cervical cancer, according to a propensity-matched analysis of data from 105 patients with recurrence.

And recurrence in the pelvic cavity and peritoneal carcinomatosis were more common after laparoscopic hysterectomy than after open surgery. Overall survival was similar between the groups, however.

The different patterns of recurrence may relate to dissemination of the disease during colpotomy, but the reasons are unknown, study author Giorgio Bogani, MD, PhD, said at the meeting sponsored by AAGL.

To examine patterns of recurrence after laparoscopic and open abdominal radical hysterectomy for cervical cancer, Dr. Bogani of the department of gynecologic surgery at the National Cancer Institute in Milan and colleagues analyzed data from patients with cervical cancer who developed recurrence after surgery at two oncologic referral centers between 1990 and 2018 (Int J Gynecol Cancer. 2020 Jul. doi: 10.1136/ijgc-2020-001381).

The investigators applied a propensity-matching algorithm to reduce possible confounding factors. They matched 35 patients who had recurrence after laparoscopic hysterectomy to 70 patients who had recurrence after open surgery. The groups had similar baseline characteristics.

As in the Laparoscopic Approach to Cervical Cancer (LACC) trial, patients who had minimally invasive surgery were more likely to have a worse disease-free survival, compared with patients who had open surgery, Dr. Bogani said. Patients who underwent laparoscopic radical hysterectomy had a median progression-free survival of 8 months, whereas patients who underwent open abdominal procedures had a median progression-free survival of 15.8 months.

Although vaginal, lymphatic, and distant recurrences were similar between the groups, a greater percentage of patients in the laparoscopic hysterectomy group had recurrence in the pelvic cavity (74% vs. 34%) and peritoneal carcinomatosis (17% vs. 1.5%).

The LACC trial, which found significantly lower disease-free and overall survival with laparoscopic hysterectomy, sent a “shockwave through the gynecologic oncology community” when it was published in 2018, said Masoud Azodi, MD, in a discussion following Dr. Bogani’s presentation.

Researchers have raised questions about that trial’s design and validity, noted Dr. Azodi, director of minimally invasive and robotic surgery at Yale University in New Haven, Conn.

It could be that local recurrences are attributable to surgical technique, rather than to the minimally invasive approach in itself, Dr. Azodi said. Prior studies of laparoscopic hysterectomy for cervical cancer had indicated better surgical outcomes and equivalent oncologic results, relative to open surgery.

Before the LACC trial, Dr. Bogani used the minimally invasive approach for almost all surgeries. Since then, he has performed open surgeries. If he were to use a minimally invasive approach now, it would be in the context of a clinical trial, Dr. Bogani said.

Dr. Bogani and Dr. Azodi had no relevant financial disclosures.

SOURCE: Bogani G et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.069.

When cervical cancer recurs after radical hysterectomy, the likelihood of recurrence at certain sites and the timing of recurrence may be associated with the surgical approach, according to a retrospective study.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

Recurrence tended to occur sooner after minimally invasive surgery than after open abdominal surgery for cervical cancer, according to a propensity-matched analysis of data from 105 patients with recurrence.

And recurrence in the pelvic cavity and peritoneal carcinomatosis were more common after laparoscopic hysterectomy than after open surgery. Overall survival was similar between the groups, however.

The different patterns of recurrence may relate to dissemination of the disease during colpotomy, but the reasons are unknown, study author Giorgio Bogani, MD, PhD, said at the meeting sponsored by AAGL.

To examine patterns of recurrence after laparoscopic and open abdominal radical hysterectomy for cervical cancer, Dr. Bogani of the department of gynecologic surgery at the National Cancer Institute in Milan and colleagues analyzed data from patients with cervical cancer who developed recurrence after surgery at two oncologic referral centers between 1990 and 2018 (Int J Gynecol Cancer. 2020 Jul. doi: 10.1136/ijgc-2020-001381).

The investigators applied a propensity-matching algorithm to reduce possible confounding factors. They matched 35 patients who had recurrence after laparoscopic hysterectomy to 70 patients who had recurrence after open surgery. The groups had similar baseline characteristics.

As in the Laparoscopic Approach to Cervical Cancer (LACC) trial, patients who had minimally invasive surgery were more likely to have a worse disease-free survival, compared with patients who had open surgery, Dr. Bogani said. Patients who underwent laparoscopic radical hysterectomy had a median progression-free survival of 8 months, whereas patients who underwent open abdominal procedures had a median progression-free survival of 15.8 months.

Although vaginal, lymphatic, and distant recurrences were similar between the groups, a greater percentage of patients in the laparoscopic hysterectomy group had recurrence in the pelvic cavity (74% vs. 34%) and peritoneal carcinomatosis (17% vs. 1.5%).

The LACC trial, which found significantly lower disease-free and overall survival with laparoscopic hysterectomy, sent a “shockwave through the gynecologic oncology community” when it was published in 2018, said Masoud Azodi, MD, in a discussion following Dr. Bogani’s presentation.

Researchers have raised questions about that trial’s design and validity, noted Dr. Azodi, director of minimally invasive and robotic surgery at Yale University in New Haven, Conn.

It could be that local recurrences are attributable to surgical technique, rather than to the minimally invasive approach in itself, Dr. Azodi said. Prior studies of laparoscopic hysterectomy for cervical cancer had indicated better surgical outcomes and equivalent oncologic results, relative to open surgery.

Before the LACC trial, Dr. Bogani used the minimally invasive approach for almost all surgeries. Since then, he has performed open surgeries. If he were to use a minimally invasive approach now, it would be in the context of a clinical trial, Dr. Bogani said.

Dr. Bogani and Dr. Azodi had no relevant financial disclosures.

SOURCE: Bogani G et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.069.

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Diabetic retinopathy may predict greater risk of COVID-19 severity

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Risk of intubation for COVID-19 in very sick hospitalized patients was increased over fivefold in those with diabetic retinopathy, compared with those without, in a small single-center study from the United Kingdom.

Importantly, the risk of intubation was independent of conventional risk factors for poor COVID-19 outcomes.

“People with preexisting diabetes-related vascular damage, such as retinopathy, might be predisposed to a more severe form of COVID-19 requiring ventilation in the intensive therapy unit,” said lead investigator Janaka Karalliedde, MBBS, PhD.

Dr. Karalliedde and colleagues note that this is “the first description of diabetic retinopathy as a potential risk factor for poor COVID-19 outcomes.”

“For this reason, looking for the presence or history of retinopathy or other vascular complications of diabetes may help health care professionals identify patients at high risk of severe COVID-19,” added Dr. Karalliedde, of Guy’s and St Thomas’ NHS Foundation Trust, London.

The study was published online in Diabetes Research and Clinical Practice.
 

Preexisting diabetic retinopathy and COVID-19 outcomes

The prevalence of diabetic retinopathy is thought to be around 55% in people with type 1 diabetes and 30% in people with type 2 diabetes, on average.

Dr. Karalliedde is part of a research group at King’s College London that has been focused on how vascular disease may predispose to more severe COVID-19.

“COVID-19 affects the blood vessels all over the body,” he said, so they wondered whether having preexisting retinopathy “would predispose to a severe manifestation of COVID-19.”

The observational study included 187 patients with diabetes (179 patients with type 2 diabetes and 8 patients with type 1 diabetes) hospitalized with COVID-19 at Guy’s and St Thomas’ NHS Foundation Trust between March 12 and April 7 (the peak of the first wave of the pandemic in the United Kingdom).  

“It was an ethnically diverse population who were very sick and provides a clinical observation of real life,” Dr. Karalliedde said.

Nearly half of patients were African Caribbean (44%), 39% were White, and 17% were of other ethnicities, including 8% who were Asian. The mean age of the cohort was 68 years (range, 22-97 years), and 60% were men.

Diabetic retinopathy was reported in 67 (36%) patients, of whom 80% had background retinopathy and 20% had more advanced retinopathy.

They then looked at whether the presence of retinopathy was associated with a more severe manifestation of COVID-19 as defined by the need for tracheal intubation.

Of the 187 patients, 26% were intubated and 45% of these patients had diabetic retinopathy.

The analysis showed those with diabetic retinopathy had an over-fivefold increased risk for intubation (odds ratio, 5.81; 95% confidence interval, 1.37-24.66).

Of the entire cohort, 32% of patients died, although no association was observed between retinopathy and mortality.

“A greater number of diabetes patients with COVID-19 ended up on the intensive therapy unit. Upon multivariate analysis, we found retinopathy was independently associated with ending up on the intensive therapy unit,” stressed Dr. Karalliedde.

However, they noted that, “due to the cross-sectional design of our study, we cannot prove causality [between retinopathy and intubation]. Further studies are required to understand the mechanisms that explain the associations between retinopathy and other indices of microangiopathy with severe COVID-19.”

A version of this article originally appeared on Medscape.com.

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Risk of intubation for COVID-19 in very sick hospitalized patients was increased over fivefold in those with diabetic retinopathy, compared with those without, in a small single-center study from the United Kingdom.

Importantly, the risk of intubation was independent of conventional risk factors for poor COVID-19 outcomes.

“People with preexisting diabetes-related vascular damage, such as retinopathy, might be predisposed to a more severe form of COVID-19 requiring ventilation in the intensive therapy unit,” said lead investigator Janaka Karalliedde, MBBS, PhD.

Dr. Karalliedde and colleagues note that this is “the first description of diabetic retinopathy as a potential risk factor for poor COVID-19 outcomes.”

“For this reason, looking for the presence or history of retinopathy or other vascular complications of diabetes may help health care professionals identify patients at high risk of severe COVID-19,” added Dr. Karalliedde, of Guy’s and St Thomas’ NHS Foundation Trust, London.

The study was published online in Diabetes Research and Clinical Practice.
 

Preexisting diabetic retinopathy and COVID-19 outcomes

The prevalence of diabetic retinopathy is thought to be around 55% in people with type 1 diabetes and 30% in people with type 2 diabetes, on average.

Dr. Karalliedde is part of a research group at King’s College London that has been focused on how vascular disease may predispose to more severe COVID-19.

“COVID-19 affects the blood vessels all over the body,” he said, so they wondered whether having preexisting retinopathy “would predispose to a severe manifestation of COVID-19.”

The observational study included 187 patients with diabetes (179 patients with type 2 diabetes and 8 patients with type 1 diabetes) hospitalized with COVID-19 at Guy’s and St Thomas’ NHS Foundation Trust between March 12 and April 7 (the peak of the first wave of the pandemic in the United Kingdom).  

“It was an ethnically diverse population who were very sick and provides a clinical observation of real life,” Dr. Karalliedde said.

Nearly half of patients were African Caribbean (44%), 39% were White, and 17% were of other ethnicities, including 8% who were Asian. The mean age of the cohort was 68 years (range, 22-97 years), and 60% were men.

Diabetic retinopathy was reported in 67 (36%) patients, of whom 80% had background retinopathy and 20% had more advanced retinopathy.

They then looked at whether the presence of retinopathy was associated with a more severe manifestation of COVID-19 as defined by the need for tracheal intubation.

Of the 187 patients, 26% were intubated and 45% of these patients had diabetic retinopathy.

The analysis showed those with diabetic retinopathy had an over-fivefold increased risk for intubation (odds ratio, 5.81; 95% confidence interval, 1.37-24.66).

Of the entire cohort, 32% of patients died, although no association was observed between retinopathy and mortality.

“A greater number of diabetes patients with COVID-19 ended up on the intensive therapy unit. Upon multivariate analysis, we found retinopathy was independently associated with ending up on the intensive therapy unit,” stressed Dr. Karalliedde.

However, they noted that, “due to the cross-sectional design of our study, we cannot prove causality [between retinopathy and intubation]. Further studies are required to understand the mechanisms that explain the associations between retinopathy and other indices of microangiopathy with severe COVID-19.”

A version of this article originally appeared on Medscape.com.

Risk of intubation for COVID-19 in very sick hospitalized patients was increased over fivefold in those with diabetic retinopathy, compared with those without, in a small single-center study from the United Kingdom.

Importantly, the risk of intubation was independent of conventional risk factors for poor COVID-19 outcomes.

“People with preexisting diabetes-related vascular damage, such as retinopathy, might be predisposed to a more severe form of COVID-19 requiring ventilation in the intensive therapy unit,” said lead investigator Janaka Karalliedde, MBBS, PhD.

Dr. Karalliedde and colleagues note that this is “the first description of diabetic retinopathy as a potential risk factor for poor COVID-19 outcomes.”

“For this reason, looking for the presence or history of retinopathy or other vascular complications of diabetes may help health care professionals identify patients at high risk of severe COVID-19,” added Dr. Karalliedde, of Guy’s and St Thomas’ NHS Foundation Trust, London.

The study was published online in Diabetes Research and Clinical Practice.
 

Preexisting diabetic retinopathy and COVID-19 outcomes

The prevalence of diabetic retinopathy is thought to be around 55% in people with type 1 diabetes and 30% in people with type 2 diabetes, on average.

Dr. Karalliedde is part of a research group at King’s College London that has been focused on how vascular disease may predispose to more severe COVID-19.

“COVID-19 affects the blood vessels all over the body,” he said, so they wondered whether having preexisting retinopathy “would predispose to a severe manifestation of COVID-19.”

The observational study included 187 patients with diabetes (179 patients with type 2 diabetes and 8 patients with type 1 diabetes) hospitalized with COVID-19 at Guy’s and St Thomas’ NHS Foundation Trust between March 12 and April 7 (the peak of the first wave of the pandemic in the United Kingdom).  

“It was an ethnically diverse population who were very sick and provides a clinical observation of real life,” Dr. Karalliedde said.

Nearly half of patients were African Caribbean (44%), 39% were White, and 17% were of other ethnicities, including 8% who were Asian. The mean age of the cohort was 68 years (range, 22-97 years), and 60% were men.

Diabetic retinopathy was reported in 67 (36%) patients, of whom 80% had background retinopathy and 20% had more advanced retinopathy.

They then looked at whether the presence of retinopathy was associated with a more severe manifestation of COVID-19 as defined by the need for tracheal intubation.

Of the 187 patients, 26% were intubated and 45% of these patients had diabetic retinopathy.

The analysis showed those with diabetic retinopathy had an over-fivefold increased risk for intubation (odds ratio, 5.81; 95% confidence interval, 1.37-24.66).

Of the entire cohort, 32% of patients died, although no association was observed between retinopathy and mortality.

“A greater number of diabetes patients with COVID-19 ended up on the intensive therapy unit. Upon multivariate analysis, we found retinopathy was independently associated with ending up on the intensive therapy unit,” stressed Dr. Karalliedde.

However, they noted that, “due to the cross-sectional design of our study, we cannot prove causality [between retinopathy and intubation]. Further studies are required to understand the mechanisms that explain the associations between retinopathy and other indices of microangiopathy with severe COVID-19.”

A version of this article originally appeared on Medscape.com.

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How Twitter amplifies my doctor and human voice

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When I graduated from residency in 2007, Facebook had just become “a thing,” and my cohort decided to use it to keep in touch. These days, Twitter seems to be the social media platform of choice for health care professionals.

KatarzynaBialasiewicz/Thinkstock

When I started on Twitter a few years ago, it was in reaction to the current political climate. I wanted to keep track of what my favorite thinkers were writing. I was anonymous and tweeted about politics mostly. My husband was my only follower for a while.

I deanonymized when, at last year’s American College of Rheumatology meeting, I presented a poster and wanted to reach a wider audience. I could have created two different personas on Twitter, like many doctors apparently do. Initially, I resisted doing that because I am frankly too lazy to keep track of two different social media profiles, but now I resist because I see my profession as an extension of my political self, and have no problem with using my (very low) profile to amplify both my doctor voice and my human voice.

Professionally, Twitter is rewarding. It is a space for networking and for promoting one’s work. It is a fantastic learning format, as evidenced by the popularity of tweetorials. The international consortium that has worked to collect information on rheumatology patients with COVID started as an idea on Twitter. The fact that ACR Convergence 2020 abstracts are now available? I only know because of the #ACRambassadors that I follow.

But I find that I cannot separate who I am from what I do. As a rheumatologist, I build long-term relationships with patients. I cannot care for their medical conditions in isolation without also concerning myself with their nonmedical circumstances. For that reason, I have opinions that one might call humanist, and I suspect that I am not alone among rheumatologists.

I can think of three areas, broadly construed but with huge overlaps, that concern me a great deal.

First, there are things that affect all physicians: race and gender discrimination in the workplace; advancement of women in science, technology, engineering, or mathMedicare reimbursementCOVID-19 preparednessimmigration issues (an issue near and dear to me, as I am an immigrant and a foreign medical graduate); and federal funding (including funding for training programs and community health centers, funding for the National Institutes of Health, and funding for stem cell research).

Then there are the things that affect rheumatologists in particular. Access to medications and procedures is one thing. (I did say these categories hugely overlap.) If you›ve ever tried to prescribe even a drug as old as oral cyclophosphamide, you’ll have experienced the difficulty of getting it for Medicare patients. Patients who need biologics are limited by insurance contracts with pharmaceutical companies, but also by requirements such as step therapy. I am all varieties of annoyed, incredulous, and apologetic that when a patient asks me how much a treatment will cost him/her, I do not have an answer.

Speaking of pricing, don’t even get me started on pharmaceutical company price gouging. Yes, the H.P. Acthar gel may be the most egregious offender among rheumatology medications, but it’s easy to not prescribe a drug that costs $80,000 a vial and which does not do much more than prednisone does. On the other hand, I remember a time when colchicine cost $0.10 cents a pill and patients did not have to jump through hoops to get it.

Dr. Karmela K. Chan

And what of reproductive freedom? Our patients rely on us for advice about their childbearing options, including birth control, in vitro fertilization, and pregnancy termination.

Finally, and most important, the things that affect me most are the issues that affect patients. The lowest-hanging fruit here is the abject incompetence of the federal response to the ongoing pandemic. How many of our patients’ lives have been lost or adversely affected? And what of coverage for preexisting conditions for the vast majority of our patients, whose illnesses are chronic?

While we’re at it, the fact of health insurance being tied to employment, something that seemingly no other country in the developed world does, makes living with chronic conditions outright scary, doesn’t it? It isn’t quite so easy to remain employed when one cannot get the right medications for RA.

I could go on. Gun violence and health care disparities, vaccine denialism, coverage for mental health issues, LGBTQ rights, refugee rights, police brutality … there is a seemingly endless list of things to care about. It’s exhausting.

While I do use my Twitter account to learn from colleagues and to promote work that interests me, my primary aim is to participate in civil society as a person. Critics will use “stay in your lane” as shorthand to say x professionals should stick to x (actors to acting, musicians to music, athletes to sports). If only I could. But my humanity won’t let me. Aristotle said man is a political animal; even the venerable New England Journal of Medicine has found it impossible to keep silent.

Karmela Kim Chan, MD, is an assistant professor at Weill Cornell Medicine, New York, and an attending physician at the Hospital for Special Surgery and Memorial Sloan Kettering Cancer Center, both in New York. Before moving to New York City, she spent 7 years in private practice in Rhode Island and was a past columnist for MDedge Rheumatology, writing about the challenges of starting life as a full-fledged rheumatologist in a private practice.
 

A version of this article originally appeared on Medscape.com.

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When I graduated from residency in 2007, Facebook had just become “a thing,” and my cohort decided to use it to keep in touch. These days, Twitter seems to be the social media platform of choice for health care professionals.

KatarzynaBialasiewicz/Thinkstock

When I started on Twitter a few years ago, it was in reaction to the current political climate. I wanted to keep track of what my favorite thinkers were writing. I was anonymous and tweeted about politics mostly. My husband was my only follower for a while.

I deanonymized when, at last year’s American College of Rheumatology meeting, I presented a poster and wanted to reach a wider audience. I could have created two different personas on Twitter, like many doctors apparently do. Initially, I resisted doing that because I am frankly too lazy to keep track of two different social media profiles, but now I resist because I see my profession as an extension of my political self, and have no problem with using my (very low) profile to amplify both my doctor voice and my human voice.

Professionally, Twitter is rewarding. It is a space for networking and for promoting one’s work. It is a fantastic learning format, as evidenced by the popularity of tweetorials. The international consortium that has worked to collect information on rheumatology patients with COVID started as an idea on Twitter. The fact that ACR Convergence 2020 abstracts are now available? I only know because of the #ACRambassadors that I follow.

But I find that I cannot separate who I am from what I do. As a rheumatologist, I build long-term relationships with patients. I cannot care for their medical conditions in isolation without also concerning myself with their nonmedical circumstances. For that reason, I have opinions that one might call humanist, and I suspect that I am not alone among rheumatologists.

I can think of three areas, broadly construed but with huge overlaps, that concern me a great deal.

First, there are things that affect all physicians: race and gender discrimination in the workplace; advancement of women in science, technology, engineering, or mathMedicare reimbursementCOVID-19 preparednessimmigration issues (an issue near and dear to me, as I am an immigrant and a foreign medical graduate); and federal funding (including funding for training programs and community health centers, funding for the National Institutes of Health, and funding for stem cell research).

Then there are the things that affect rheumatologists in particular. Access to medications and procedures is one thing. (I did say these categories hugely overlap.) If you›ve ever tried to prescribe even a drug as old as oral cyclophosphamide, you’ll have experienced the difficulty of getting it for Medicare patients. Patients who need biologics are limited by insurance contracts with pharmaceutical companies, but also by requirements such as step therapy. I am all varieties of annoyed, incredulous, and apologetic that when a patient asks me how much a treatment will cost him/her, I do not have an answer.

Speaking of pricing, don’t even get me started on pharmaceutical company price gouging. Yes, the H.P. Acthar gel may be the most egregious offender among rheumatology medications, but it’s easy to not prescribe a drug that costs $80,000 a vial and which does not do much more than prednisone does. On the other hand, I remember a time when colchicine cost $0.10 cents a pill and patients did not have to jump through hoops to get it.

Dr. Karmela K. Chan

And what of reproductive freedom? Our patients rely on us for advice about their childbearing options, including birth control, in vitro fertilization, and pregnancy termination.

Finally, and most important, the things that affect me most are the issues that affect patients. The lowest-hanging fruit here is the abject incompetence of the federal response to the ongoing pandemic. How many of our patients’ lives have been lost or adversely affected? And what of coverage for preexisting conditions for the vast majority of our patients, whose illnesses are chronic?

While we’re at it, the fact of health insurance being tied to employment, something that seemingly no other country in the developed world does, makes living with chronic conditions outright scary, doesn’t it? It isn’t quite so easy to remain employed when one cannot get the right medications for RA.

I could go on. Gun violence and health care disparities, vaccine denialism, coverage for mental health issues, LGBTQ rights, refugee rights, police brutality … there is a seemingly endless list of things to care about. It’s exhausting.

While I do use my Twitter account to learn from colleagues and to promote work that interests me, my primary aim is to participate in civil society as a person. Critics will use “stay in your lane” as shorthand to say x professionals should stick to x (actors to acting, musicians to music, athletes to sports). If only I could. But my humanity won’t let me. Aristotle said man is a political animal; even the venerable New England Journal of Medicine has found it impossible to keep silent.

Karmela Kim Chan, MD, is an assistant professor at Weill Cornell Medicine, New York, and an attending physician at the Hospital for Special Surgery and Memorial Sloan Kettering Cancer Center, both in New York. Before moving to New York City, she spent 7 years in private practice in Rhode Island and was a past columnist for MDedge Rheumatology, writing about the challenges of starting life as a full-fledged rheumatologist in a private practice.
 

A version of this article originally appeared on Medscape.com.

When I graduated from residency in 2007, Facebook had just become “a thing,” and my cohort decided to use it to keep in touch. These days, Twitter seems to be the social media platform of choice for health care professionals.

KatarzynaBialasiewicz/Thinkstock

When I started on Twitter a few years ago, it was in reaction to the current political climate. I wanted to keep track of what my favorite thinkers were writing. I was anonymous and tweeted about politics mostly. My husband was my only follower for a while.

I deanonymized when, at last year’s American College of Rheumatology meeting, I presented a poster and wanted to reach a wider audience. I could have created two different personas on Twitter, like many doctors apparently do. Initially, I resisted doing that because I am frankly too lazy to keep track of two different social media profiles, but now I resist because I see my profession as an extension of my political self, and have no problem with using my (very low) profile to amplify both my doctor voice and my human voice.

Professionally, Twitter is rewarding. It is a space for networking and for promoting one’s work. It is a fantastic learning format, as evidenced by the popularity of tweetorials. The international consortium that has worked to collect information on rheumatology patients with COVID started as an idea on Twitter. The fact that ACR Convergence 2020 abstracts are now available? I only know because of the #ACRambassadors that I follow.

But I find that I cannot separate who I am from what I do. As a rheumatologist, I build long-term relationships with patients. I cannot care for their medical conditions in isolation without also concerning myself with their nonmedical circumstances. For that reason, I have opinions that one might call humanist, and I suspect that I am not alone among rheumatologists.

I can think of three areas, broadly construed but with huge overlaps, that concern me a great deal.

First, there are things that affect all physicians: race and gender discrimination in the workplace; advancement of women in science, technology, engineering, or mathMedicare reimbursementCOVID-19 preparednessimmigration issues (an issue near and dear to me, as I am an immigrant and a foreign medical graduate); and federal funding (including funding for training programs and community health centers, funding for the National Institutes of Health, and funding for stem cell research).

Then there are the things that affect rheumatologists in particular. Access to medications and procedures is one thing. (I did say these categories hugely overlap.) If you›ve ever tried to prescribe even a drug as old as oral cyclophosphamide, you’ll have experienced the difficulty of getting it for Medicare patients. Patients who need biologics are limited by insurance contracts with pharmaceutical companies, but also by requirements such as step therapy. I am all varieties of annoyed, incredulous, and apologetic that when a patient asks me how much a treatment will cost him/her, I do not have an answer.

Speaking of pricing, don’t even get me started on pharmaceutical company price gouging. Yes, the H.P. Acthar gel may be the most egregious offender among rheumatology medications, but it’s easy to not prescribe a drug that costs $80,000 a vial and which does not do much more than prednisone does. On the other hand, I remember a time when colchicine cost $0.10 cents a pill and patients did not have to jump through hoops to get it.

Dr. Karmela K. Chan

And what of reproductive freedom? Our patients rely on us for advice about their childbearing options, including birth control, in vitro fertilization, and pregnancy termination.

Finally, and most important, the things that affect me most are the issues that affect patients. The lowest-hanging fruit here is the abject incompetence of the federal response to the ongoing pandemic. How many of our patients’ lives have been lost or adversely affected? And what of coverage for preexisting conditions for the vast majority of our patients, whose illnesses are chronic?

While we’re at it, the fact of health insurance being tied to employment, something that seemingly no other country in the developed world does, makes living with chronic conditions outright scary, doesn’t it? It isn’t quite so easy to remain employed when one cannot get the right medications for RA.

I could go on. Gun violence and health care disparities, vaccine denialism, coverage for mental health issues, LGBTQ rights, refugee rights, police brutality … there is a seemingly endless list of things to care about. It’s exhausting.

While I do use my Twitter account to learn from colleagues and to promote work that interests me, my primary aim is to participate in civil society as a person. Critics will use “stay in your lane” as shorthand to say x professionals should stick to x (actors to acting, musicians to music, athletes to sports). If only I could. But my humanity won’t let me. Aristotle said man is a political animal; even the venerable New England Journal of Medicine has found it impossible to keep silent.

Karmela Kim Chan, MD, is an assistant professor at Weill Cornell Medicine, New York, and an attending physician at the Hospital for Special Surgery and Memorial Sloan Kettering Cancer Center, both in New York. Before moving to New York City, she spent 7 years in private practice in Rhode Island and was a past columnist for MDedge Rheumatology, writing about the challenges of starting life as a full-fledged rheumatologist in a private practice.
 

A version of this article originally appeared on Medscape.com.

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COVID-19 vaccine distribution could start in 2 weeks, Pence says

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Thu, 08/26/2021 - 15:55

Initial doses of a coronavirus vaccine could be sent out as early as mid-December, Vice President Mike Pence told governors during a call on Monday.

The distribution process could start during the week of Dec. 14, according to audio of a White House Coronavirus Task Force call obtained by CBS News. The call focused on the timeline of vaccine approval and distribution.

“With this morning’s news that Moderna is joining Pfizer in submitting an emergency-use authorization [to the Food and Drug Administration], we continue to be on pace,” Pence said.

The FDA is scheduled to make a decision about Pfizer’s emergency use authorization after an advisory panel meets on Dec. 10 to review the company’s application. FDA Commissioner Stephen Hahn, MD, didn’t commit to the Dec. 14 date, CBS News reported.

“We do all the number crunching ourselves,” Dr. Hahn said. “We look line by line by line on all the data, on all the patients and manufacturing. We do statistical analyses and we come to our own conclusions to support a decision of either thumbs-up or thumbs-down.”

According to a meeting agenda, Pfizer vaccine deliveries should start on Dec. 15, followed by the Moderna vaccine on Dec. 22, CBS News reported.

Between Dec. 13-19, Pfizer is slated to deliver 6.4 million doses, which is enough to immunize about 3 million people with two shots. An “undetermined number” are reserved for backup doses, the news outlet reported.

During the next week, Pfizer and Moderna are scheduled to produce enough doses to vaccinate an additional 10 million people. By the end of the month, about 30 million people should receive doses.

As vaccines begin to roll out, Mr. Pence said “we have a ways to go” in reassuring the public about immunization. He urged governors to use their “bully pulpit” to educate their states and “develop public confidence” in the vaccines.

During the call, Anthony Fauci, MD, director of the National Institute for Allergy and Infectious Diseases, supported the safety and efficacy of the vaccines. Although the vaccine development and approval process was accelerated this year, he said, it “does not at all compromise safety, nor does it compromise scientific integrity.”

“Any misrepresentation that the vaccines had government interference or company interference is patently untrue,” he said.

This article first appeared on Medscape.com.

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Initial doses of a coronavirus vaccine could be sent out as early as mid-December, Vice President Mike Pence told governors during a call on Monday.

The distribution process could start during the week of Dec. 14, according to audio of a White House Coronavirus Task Force call obtained by CBS News. The call focused on the timeline of vaccine approval and distribution.

“With this morning’s news that Moderna is joining Pfizer in submitting an emergency-use authorization [to the Food and Drug Administration], we continue to be on pace,” Pence said.

The FDA is scheduled to make a decision about Pfizer’s emergency use authorization after an advisory panel meets on Dec. 10 to review the company’s application. FDA Commissioner Stephen Hahn, MD, didn’t commit to the Dec. 14 date, CBS News reported.

“We do all the number crunching ourselves,” Dr. Hahn said. “We look line by line by line on all the data, on all the patients and manufacturing. We do statistical analyses and we come to our own conclusions to support a decision of either thumbs-up or thumbs-down.”

According to a meeting agenda, Pfizer vaccine deliveries should start on Dec. 15, followed by the Moderna vaccine on Dec. 22, CBS News reported.

Between Dec. 13-19, Pfizer is slated to deliver 6.4 million doses, which is enough to immunize about 3 million people with two shots. An “undetermined number” are reserved for backup doses, the news outlet reported.

During the next week, Pfizer and Moderna are scheduled to produce enough doses to vaccinate an additional 10 million people. By the end of the month, about 30 million people should receive doses.

As vaccines begin to roll out, Mr. Pence said “we have a ways to go” in reassuring the public about immunization. He urged governors to use their “bully pulpit” to educate their states and “develop public confidence” in the vaccines.

During the call, Anthony Fauci, MD, director of the National Institute for Allergy and Infectious Diseases, supported the safety and efficacy of the vaccines. Although the vaccine development and approval process was accelerated this year, he said, it “does not at all compromise safety, nor does it compromise scientific integrity.”

“Any misrepresentation that the vaccines had government interference or company interference is patently untrue,” he said.

This article first appeared on Medscape.com.

Initial doses of a coronavirus vaccine could be sent out as early as mid-December, Vice President Mike Pence told governors during a call on Monday.

The distribution process could start during the week of Dec. 14, according to audio of a White House Coronavirus Task Force call obtained by CBS News. The call focused on the timeline of vaccine approval and distribution.

“With this morning’s news that Moderna is joining Pfizer in submitting an emergency-use authorization [to the Food and Drug Administration], we continue to be on pace,” Pence said.

The FDA is scheduled to make a decision about Pfizer’s emergency use authorization after an advisory panel meets on Dec. 10 to review the company’s application. FDA Commissioner Stephen Hahn, MD, didn’t commit to the Dec. 14 date, CBS News reported.

“We do all the number crunching ourselves,” Dr. Hahn said. “We look line by line by line on all the data, on all the patients and manufacturing. We do statistical analyses and we come to our own conclusions to support a decision of either thumbs-up or thumbs-down.”

According to a meeting agenda, Pfizer vaccine deliveries should start on Dec. 15, followed by the Moderna vaccine on Dec. 22, CBS News reported.

Between Dec. 13-19, Pfizer is slated to deliver 6.4 million doses, which is enough to immunize about 3 million people with two shots. An “undetermined number” are reserved for backup doses, the news outlet reported.

During the next week, Pfizer and Moderna are scheduled to produce enough doses to vaccinate an additional 10 million people. By the end of the month, about 30 million people should receive doses.

As vaccines begin to roll out, Mr. Pence said “we have a ways to go” in reassuring the public about immunization. He urged governors to use their “bully pulpit” to educate their states and “develop public confidence” in the vaccines.

During the call, Anthony Fauci, MD, director of the National Institute for Allergy and Infectious Diseases, supported the safety and efficacy of the vaccines. Although the vaccine development and approval process was accelerated this year, he said, it “does not at all compromise safety, nor does it compromise scientific integrity.”

“Any misrepresentation that the vaccines had government interference or company interference is patently untrue,” he said.

This article first appeared on Medscape.com.

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Medicare finalizes 2021 physician pay rule with E/M changes

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Mon, 01/04/2021 - 12:37

Medicare officials stuck with their plan to increase payments for office visits for primary care and several other specialties that focus on helping patients manage complex conditions such as diabetes. In doing so, Medicare also finalized cuts for other fields, triggering a new wave of protests.

The final version of the 2021 Medicare physician fee schedule was unveiled on the night of Dec. 1. The Centers for Medicare & Medicaid Services posted an unofficial copy of the rule, which will later be published in the Federal Register.

CMS said it completed work on this massive annual review of payments for clinicians later than it usually does because of the demands of the federal response to the COVID-19 pandemic. The 2021 physician fee rule will take effect within a 30-day period instead of the usual 60-day time frame.

The rule, which runs to more than 2,100 pages, makes myriad changes in Medicare policies, including rules on telehealth, and expands the roles of nurse practitioners and physician assistants.

The most contentious item proposed for 2021 was a reshuffling of payments among specialties as part of an overhaul of Medicare’s approach to valuing evaluation and management (E/M) services. There was broader support for other aspects of the E/M overhaul, which are intended to cut some of the administrative hassle clinicians face.

“This finalized policy marks the most significant updates to E/M codes in 30 years, reducing burden on doctors imposed by the coding system and rewarding time spent evaluating and managing their patients’ care,” CMS Administrator Seema Verma said in a statement. “In the past, the system has rewarded interventions and procedures over time spent with patients – time taken preventing disease and managing chronic illnesses.”

In the final rule, CMS summarized these results of the E/M changes in Table 106. CMS largely stuck with the approach outlined in a draft rule released in August, with minor changes in the amounts of cuts and increases.

Specialties in line for increases under the 2021 final physician fee schedule include allergy/immunology (9%), endocrinology (16%), family practice (13%), general practice (7%), geriatrics (3%), hematology/oncology (14%), internal medicine (4%), nephrology (6%), physician assistants (8%), psychiatry (7%), rheumatology (15%), and urology (8%).

In line for cuts would be anesthesiology (–8%), cardiac surgery (–8%), emergency medicine (–6%), general surgery (–6%), infectious disease (–4%), neurosurgery (–6%), physical/occupational therapy (–9%), plastic surgery (–7%), radiology (–10%), and thoracic surgery (–8%).

CMS had initially set these changes in 2021 pay in motion in the 2020 physician fee schedule. The agency subsequently faced significant opposition to its plans. Many physician groups sought to waive a “budget-neutral” approach to the E/M overhaul, which makes the offsetting of cuts necessary. They argued this would allow increased compensation for clinicians whose practices focus on office visits without requiring offsetting cuts from other fields of medicine.

The American Medical Association is among those urging Congress to prevent or postpone the payment reductions resulting from Medicare’s budget neutrality requirement as applied to the E/M overhaul.

In a Tuesday statement, AMA President Susan R. Bailey, MD, noted that many physicians are facing “substantial economic hardships due to COVID-19.”

By AMA’s calculations, CMS’ planned 2021 E/M overhaul could result in “a shocking reduction of 10.2% to Medicare payment rates,” according to Bailey’s statement. The AMA strongly supports other aspects of the E/M changes CMS finalized, which Bailey said will result in “simpler and more flexible” coding and documentation.

The Surgical Care Coalition, which represents about a dozen medical specialty associations, is asking members of Congress to block the full implementation of the E/M overhaul.

In a Dec. 1 statement, the coalition urged the passage of a bill (HR 8702) that has been introduced in the House by a bipartisan duo of physicians, Rep. Ami Bera, MD (D-Calif.), and Rep. Larry Bucshon, MD (R-Ind.). Their bill would effectively block the cuts from going into effect on January 1, 2021. It would provide an additional Medicare payment for certain services in 2021 and 2022 if the otherwise applicable payment is less than it would have been in 2020.

The Medicare E/M overhaul “was a dangerous policy even before the pandemic, and enacting it during the worst health care crisis in a century is unconscionable. If Congress fails to act, it will further strain a health care system that’s already been pushed to the brink due to the COVID-19 pandemic and undermine patient care,” said John A. Wilson, MD, president of the American Association of Neurological Surgeons, in a statement.

Also backing the Bera-Bucshon bill is the American College of Emergency Physicians. In a statement on Tuesday, ACEP President Mark Rosenberg, DO, MBA, urged Congress to act on this measure.

“Emergency physicians and other health care providers battling on the front lines of the ongoing pandemic are already under unprecedented financial strain as they continue to bear the brunt of COVID-19,” Dr. Rosenberg said. “These cuts would have a devastating impact for the future of emergency medicine and could seriously impede patients’ access to emergency care when they need it most.”
 

 

 

“Long overdue”

But there also are champions for the approach CMS took in the E/M overhaul. The influential Medicare Payment Advisory Commission (MedPAC) has argued strongly for keeping the budget-neutral approach to the E/M overhaul.

In an Oct. 2 comment to CMS about the draft 2021 physician fee schedule, MedPAC Chairman Michael E. Chernew, PhD, said this approach would “help rebalance the fee schedule from services that have become overvalued to services that have become undervalued.”

This budget-neutral approach also “will go further in reducing the large gap in compensation between primary care physicians (who had a median income of $243,000 in 2018) and specialists such as surgeons (whose median income was $426,000 in 2018),” Dr. Chernew wrote.

In a Tuesday tweet, Robert B. Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians, said CMS had “finalized long overdue payment increases for primary and comprehensive care including an add-in for more complex visits.”

The American Academy of Family Physicians joined ACP in a November 30 letter to congressional leaders, urging them to allow Medicare “to increase investment in primary care, benefiting millions of Medicare patients and the program itself, and reject last minute efforts to prevent these essential and long-overdue changes from going fully into effect on January 1, 2021.”

In the letter, AAFP and ACP and their cosigners argued for a need to address “underinvestment” in primary care by finalizing the E/M overhaul.

“Given that six in ten American adults have a chronic disease and four in ten have two or more chronic conditions, why would we, as a country, accept such an inadequate investment in the very care model that stands to provide maximum value to these patients?” they wrote. “Since we know that individuals with a longitudinal relationship with a primary care physician have better health outcomes and use fewer health care resources, why would we continue to direct money to higher-cost, marginal value services?”

A version of this article originally appeared on Medscape.com.

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Medicare officials stuck with their plan to increase payments for office visits for primary care and several other specialties that focus on helping patients manage complex conditions such as diabetes. In doing so, Medicare also finalized cuts for other fields, triggering a new wave of protests.

The final version of the 2021 Medicare physician fee schedule was unveiled on the night of Dec. 1. The Centers for Medicare & Medicaid Services posted an unofficial copy of the rule, which will later be published in the Federal Register.

CMS said it completed work on this massive annual review of payments for clinicians later than it usually does because of the demands of the federal response to the COVID-19 pandemic. The 2021 physician fee rule will take effect within a 30-day period instead of the usual 60-day time frame.

The rule, which runs to more than 2,100 pages, makes myriad changes in Medicare policies, including rules on telehealth, and expands the roles of nurse practitioners and physician assistants.

The most contentious item proposed for 2021 was a reshuffling of payments among specialties as part of an overhaul of Medicare’s approach to valuing evaluation and management (E/M) services. There was broader support for other aspects of the E/M overhaul, which are intended to cut some of the administrative hassle clinicians face.

“This finalized policy marks the most significant updates to E/M codes in 30 years, reducing burden on doctors imposed by the coding system and rewarding time spent evaluating and managing their patients’ care,” CMS Administrator Seema Verma said in a statement. “In the past, the system has rewarded interventions and procedures over time spent with patients – time taken preventing disease and managing chronic illnesses.”

In the final rule, CMS summarized these results of the E/M changes in Table 106. CMS largely stuck with the approach outlined in a draft rule released in August, with minor changes in the amounts of cuts and increases.

Specialties in line for increases under the 2021 final physician fee schedule include allergy/immunology (9%), endocrinology (16%), family practice (13%), general practice (7%), geriatrics (3%), hematology/oncology (14%), internal medicine (4%), nephrology (6%), physician assistants (8%), psychiatry (7%), rheumatology (15%), and urology (8%).

In line for cuts would be anesthesiology (–8%), cardiac surgery (–8%), emergency medicine (–6%), general surgery (–6%), infectious disease (–4%), neurosurgery (–6%), physical/occupational therapy (–9%), plastic surgery (–7%), radiology (–10%), and thoracic surgery (–8%).

CMS had initially set these changes in 2021 pay in motion in the 2020 physician fee schedule. The agency subsequently faced significant opposition to its plans. Many physician groups sought to waive a “budget-neutral” approach to the E/M overhaul, which makes the offsetting of cuts necessary. They argued this would allow increased compensation for clinicians whose practices focus on office visits without requiring offsetting cuts from other fields of medicine.

The American Medical Association is among those urging Congress to prevent or postpone the payment reductions resulting from Medicare’s budget neutrality requirement as applied to the E/M overhaul.

In a Tuesday statement, AMA President Susan R. Bailey, MD, noted that many physicians are facing “substantial economic hardships due to COVID-19.”

By AMA’s calculations, CMS’ planned 2021 E/M overhaul could result in “a shocking reduction of 10.2% to Medicare payment rates,” according to Bailey’s statement. The AMA strongly supports other aspects of the E/M changes CMS finalized, which Bailey said will result in “simpler and more flexible” coding and documentation.

The Surgical Care Coalition, which represents about a dozen medical specialty associations, is asking members of Congress to block the full implementation of the E/M overhaul.

In a Dec. 1 statement, the coalition urged the passage of a bill (HR 8702) that has been introduced in the House by a bipartisan duo of physicians, Rep. Ami Bera, MD (D-Calif.), and Rep. Larry Bucshon, MD (R-Ind.). Their bill would effectively block the cuts from going into effect on January 1, 2021. It would provide an additional Medicare payment for certain services in 2021 and 2022 if the otherwise applicable payment is less than it would have been in 2020.

The Medicare E/M overhaul “was a dangerous policy even before the pandemic, and enacting it during the worst health care crisis in a century is unconscionable. If Congress fails to act, it will further strain a health care system that’s already been pushed to the brink due to the COVID-19 pandemic and undermine patient care,” said John A. Wilson, MD, president of the American Association of Neurological Surgeons, in a statement.

Also backing the Bera-Bucshon bill is the American College of Emergency Physicians. In a statement on Tuesday, ACEP President Mark Rosenberg, DO, MBA, urged Congress to act on this measure.

“Emergency physicians and other health care providers battling on the front lines of the ongoing pandemic are already under unprecedented financial strain as they continue to bear the brunt of COVID-19,” Dr. Rosenberg said. “These cuts would have a devastating impact for the future of emergency medicine and could seriously impede patients’ access to emergency care when they need it most.”
 

 

 

“Long overdue”

But there also are champions for the approach CMS took in the E/M overhaul. The influential Medicare Payment Advisory Commission (MedPAC) has argued strongly for keeping the budget-neutral approach to the E/M overhaul.

In an Oct. 2 comment to CMS about the draft 2021 physician fee schedule, MedPAC Chairman Michael E. Chernew, PhD, said this approach would “help rebalance the fee schedule from services that have become overvalued to services that have become undervalued.”

This budget-neutral approach also “will go further in reducing the large gap in compensation between primary care physicians (who had a median income of $243,000 in 2018) and specialists such as surgeons (whose median income was $426,000 in 2018),” Dr. Chernew wrote.

In a Tuesday tweet, Robert B. Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians, said CMS had “finalized long overdue payment increases for primary and comprehensive care including an add-in for more complex visits.”

The American Academy of Family Physicians joined ACP in a November 30 letter to congressional leaders, urging them to allow Medicare “to increase investment in primary care, benefiting millions of Medicare patients and the program itself, and reject last minute efforts to prevent these essential and long-overdue changes from going fully into effect on January 1, 2021.”

In the letter, AAFP and ACP and their cosigners argued for a need to address “underinvestment” in primary care by finalizing the E/M overhaul.

“Given that six in ten American adults have a chronic disease and four in ten have two or more chronic conditions, why would we, as a country, accept such an inadequate investment in the very care model that stands to provide maximum value to these patients?” they wrote. “Since we know that individuals with a longitudinal relationship with a primary care physician have better health outcomes and use fewer health care resources, why would we continue to direct money to higher-cost, marginal value services?”

A version of this article originally appeared on Medscape.com.

Medicare officials stuck with their plan to increase payments for office visits for primary care and several other specialties that focus on helping patients manage complex conditions such as diabetes. In doing so, Medicare also finalized cuts for other fields, triggering a new wave of protests.

The final version of the 2021 Medicare physician fee schedule was unveiled on the night of Dec. 1. The Centers for Medicare & Medicaid Services posted an unofficial copy of the rule, which will later be published in the Federal Register.

CMS said it completed work on this massive annual review of payments for clinicians later than it usually does because of the demands of the federal response to the COVID-19 pandemic. The 2021 physician fee rule will take effect within a 30-day period instead of the usual 60-day time frame.

The rule, which runs to more than 2,100 pages, makes myriad changes in Medicare policies, including rules on telehealth, and expands the roles of nurse practitioners and physician assistants.

The most contentious item proposed for 2021 was a reshuffling of payments among specialties as part of an overhaul of Medicare’s approach to valuing evaluation and management (E/M) services. There was broader support for other aspects of the E/M overhaul, which are intended to cut some of the administrative hassle clinicians face.

“This finalized policy marks the most significant updates to E/M codes in 30 years, reducing burden on doctors imposed by the coding system and rewarding time spent evaluating and managing their patients’ care,” CMS Administrator Seema Verma said in a statement. “In the past, the system has rewarded interventions and procedures over time spent with patients – time taken preventing disease and managing chronic illnesses.”

In the final rule, CMS summarized these results of the E/M changes in Table 106. CMS largely stuck with the approach outlined in a draft rule released in August, with minor changes in the amounts of cuts and increases.

Specialties in line for increases under the 2021 final physician fee schedule include allergy/immunology (9%), endocrinology (16%), family practice (13%), general practice (7%), geriatrics (3%), hematology/oncology (14%), internal medicine (4%), nephrology (6%), physician assistants (8%), psychiatry (7%), rheumatology (15%), and urology (8%).

In line for cuts would be anesthesiology (–8%), cardiac surgery (–8%), emergency medicine (–6%), general surgery (–6%), infectious disease (–4%), neurosurgery (–6%), physical/occupational therapy (–9%), plastic surgery (–7%), radiology (–10%), and thoracic surgery (–8%).

CMS had initially set these changes in 2021 pay in motion in the 2020 physician fee schedule. The agency subsequently faced significant opposition to its plans. Many physician groups sought to waive a “budget-neutral” approach to the E/M overhaul, which makes the offsetting of cuts necessary. They argued this would allow increased compensation for clinicians whose practices focus on office visits without requiring offsetting cuts from other fields of medicine.

The American Medical Association is among those urging Congress to prevent or postpone the payment reductions resulting from Medicare’s budget neutrality requirement as applied to the E/M overhaul.

In a Tuesday statement, AMA President Susan R. Bailey, MD, noted that many physicians are facing “substantial economic hardships due to COVID-19.”

By AMA’s calculations, CMS’ planned 2021 E/M overhaul could result in “a shocking reduction of 10.2% to Medicare payment rates,” according to Bailey’s statement. The AMA strongly supports other aspects of the E/M changes CMS finalized, which Bailey said will result in “simpler and more flexible” coding and documentation.

The Surgical Care Coalition, which represents about a dozen medical specialty associations, is asking members of Congress to block the full implementation of the E/M overhaul.

In a Dec. 1 statement, the coalition urged the passage of a bill (HR 8702) that has been introduced in the House by a bipartisan duo of physicians, Rep. Ami Bera, MD (D-Calif.), and Rep. Larry Bucshon, MD (R-Ind.). Their bill would effectively block the cuts from going into effect on January 1, 2021. It would provide an additional Medicare payment for certain services in 2021 and 2022 if the otherwise applicable payment is less than it would have been in 2020.

The Medicare E/M overhaul “was a dangerous policy even before the pandemic, and enacting it during the worst health care crisis in a century is unconscionable. If Congress fails to act, it will further strain a health care system that’s already been pushed to the brink due to the COVID-19 pandemic and undermine patient care,” said John A. Wilson, MD, president of the American Association of Neurological Surgeons, in a statement.

Also backing the Bera-Bucshon bill is the American College of Emergency Physicians. In a statement on Tuesday, ACEP President Mark Rosenberg, DO, MBA, urged Congress to act on this measure.

“Emergency physicians and other health care providers battling on the front lines of the ongoing pandemic are already under unprecedented financial strain as they continue to bear the brunt of COVID-19,” Dr. Rosenberg said. “These cuts would have a devastating impact for the future of emergency medicine and could seriously impede patients’ access to emergency care when they need it most.”
 

 

 

“Long overdue”

But there also are champions for the approach CMS took in the E/M overhaul. The influential Medicare Payment Advisory Commission (MedPAC) has argued strongly for keeping the budget-neutral approach to the E/M overhaul.

In an Oct. 2 comment to CMS about the draft 2021 physician fee schedule, MedPAC Chairman Michael E. Chernew, PhD, said this approach would “help rebalance the fee schedule from services that have become overvalued to services that have become undervalued.”

This budget-neutral approach also “will go further in reducing the large gap in compensation between primary care physicians (who had a median income of $243,000 in 2018) and specialists such as surgeons (whose median income was $426,000 in 2018),” Dr. Chernew wrote.

In a Tuesday tweet, Robert B. Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians, said CMS had “finalized long overdue payment increases for primary and comprehensive care including an add-in for more complex visits.”

The American Academy of Family Physicians joined ACP in a November 30 letter to congressional leaders, urging them to allow Medicare “to increase investment in primary care, benefiting millions of Medicare patients and the program itself, and reject last minute efforts to prevent these essential and long-overdue changes from going fully into effect on January 1, 2021.”

In the letter, AAFP and ACP and their cosigners argued for a need to address “underinvestment” in primary care by finalizing the E/M overhaul.

“Given that six in ten American adults have a chronic disease and four in ten have two or more chronic conditions, why would we, as a country, accept such an inadequate investment in the very care model that stands to provide maximum value to these patients?” they wrote. “Since we know that individuals with a longitudinal relationship with a primary care physician have better health outcomes and use fewer health care resources, why would we continue to direct money to higher-cost, marginal value services?”

A version of this article originally appeared on Medscape.com.

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